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Completed

NCT Number: NCT06572358

A Clinical Study to Assess the Safety and Effectiveness of Test Product in Healthy Adult Human Subjects Having Symptoms of Gut Dysbiosis (Heart Burn, Bloating, Constipation and Gut Immunity).

This is prospective, open-label, single-arm, proof of science, clinical safety and efficacy study of MetProUltima in healthy adult human subjects having symptoms of Gut Dysbiosis (heart burn, bloating, constipation).

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Key information

Conditions

Gut Dysbiosis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NovoBliss Research Pvt.Ltd

Ahmedabad, Gujarat, 382481, India

About this study

A total of up to 14 subjects will be enrolled to get 12 evaluable subjects complete the study.

The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. Subjects having symptoms of gut dysbiosis like burning sensation, bloating nausea and altered bowel habit, digestion issues, aching joints and high tendency of falling sick, chronic fatigue, constipation, diarrhoea will be enrolled in the study. The subjects will be instructed to visit the facility as per the below visits.

Visit 01 (Day -01): Screening, Blood Sample Collection Visit 02 (Day 01): Enrolment, Faecal Sample Collection, Test Product Dispensing Visit 03 (Day 45 ±2 Days): Treatment usage period, Evaluations Visit 04 (Day 90 ±2 Days): Treatment usage period, Evaluations and End of study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18 to 65 years (both inclusive) at the time of consent.
  • Sex: Healthy males and healthy non-pregnant/non-lactating females.
  • Females of childbearing potential must have a self-reported negative pregnancy test.
  • Subject should have refrigerator at their home for storage of test product.
  • Subjects having history of falling sick frequently in two months.
  • Subjects having gut dysbiosis with either of these three symptoms which includes burning sensation, bloating, nausea, altered bowel habit, digestion issues, aching joints and high tendency of falling sick, chronic fatigue, constipation, diarrhoea etc.
  • If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence).
  • Subjects are willing to give written informed consent and are willing to come for regular follow-up.
  • Subjects who commit not to use other probiotics, symbiotic, prebiotics, medicated treatments or food having high probiotics other than the test product for the entire duration of the study.
  • Subject who has not participated in a similar investigation in the past three months.
  • Willing to use test product throughout the study period.

Exclusion criteria

  • Subject with suspected or proved organic causes of constipation, such as Hirschsprung's disease, hypothyroidism, or structural anomalies of the anal canal.
  • Subject with present condition of allergic response to any probiotic product.
  • Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
  • Subjects with any major diseases of the cardiovascular, renal, hepatic, gastrointestinal, pulmonary or endocrine systems.
  • History of alcohol or drug addiction.
  • Subjects with a history of major gastrointestinal complications (i.e. Crohn's disease, ulcer, cancer, ulcerative colitis).
  • Subjects who have self-reported immuno-compromised (HIV positive, on anti-rejection medication, rheumatoid arthritis).
  • Pregnant or breastfeeding or planning to become pregnant during the study period.
  • Subjects participating in other similar product or therapeutic trials within the last four weeks.

Treatment and study plan

MetProUltima

Other

Test product Name: MetProUltima Marketed By| Manufactured By: Meteoric Biopharmaceuticals Private Limited Mode of Usage: Take one capsule after each meal, twice daily. Frequency: Twice a Day Route of Administration: Oral

Primary outcomes

  1. Changes in stool consistency based on the Bristol Stool Criteria

    Time frame: Baseline before usage of the test product on Day 01, and after usage of the test product on Day 45 and on Day 90

    To evaluate the effectiveness of the test product in terms of change in stool based on the Bristol Stool Criteria categorizes stools into one of seven stool types ranging from type 1 (hard lumps) to type 7 (watery diarrhoea).

  2. Change in faecal microbiota using 16s Metagenome sequencing

    Time frame: Baseline at Day 1, and on Day 90.

    To evaluate the effectiveness of test product in terms of change in faecal microbiota using 16s Metagenome sequencing

  3. Abbreviated physical examinations in terms of frequency of sensation of defecation

    Time frame: Baseline Day 1, Day 45 and on Day 90

    To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of frequency of sensation of defecation according to a 5-point Likert scale, with a score ranging from 0 (no symptoms) to 20 (very severe symptoms

  4. Abbreviated physical examinations in terms of bloating

    Time frame: Baseline Day 1, Day 45 and on Day 90

    To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of bloating in which scoring done as less than 1 week=1, less than1 month=2, less than 2 months=3 and more than 2 months=4

  5. Abbreviated physical examinations in terms of nausea

    Time frame: Baseline Day 1, Day 45 and on Day 90

    To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of nausea where scoring determined no nausea=0, mild nausea=1-2, moderate nausea 3-6, and severe nausea7-9

  6. Abbreviated physical examinations in terms of altered bowel habit.

    Time frame: Baseline Day 1, Day 45 and on Day 90

    To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of altered bowel habit in which scoring done as less than 1 week=1, less than1 month=2, less than 2 months=3 and more than 2 months=4

  7. Abbreviated physical examinations in terms of digestion issues

    Time frame: Baseline Day 1, Day 45 and on Day 90

    To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of digestion issues in which scoring done on yes or no

  8. Abbreviated physical examinations in terms of aching joints

    Time frame: Baseline Day 1, Day 45 and on Day 90

    To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of aching joints in which scoring done as less than 1 week=1, less than1 month=2, less than 2 months=3 and more than 2 months=4

  9. Abbreviated physical examinations in terms of chronic fatigue

    Time frame: Baseline Day 1, Day 45 and on Day 90

    To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of chronic fatigue in which scoring done as less than 1 week=1, less than1 month=2, less than 6 months=3 and more than 6 months=4

  10. Abbreviated physical examinations in terms of constipation for Frequency of bowel movements

    Time frame: Baseline Day 1, Day 45 and on Day 90

    To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Frequency of bowel movements in which scoring done 1-2 times per 1-2 days=1 and less than once per month=4

  11. Abbreviated physical examinations in terms of constipation for Completeness: feeling incomplete evacuation

    Time frame: Baseline Day 1, Day 45 and on Day 90

    To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Completeness: feeling incomplete evacuation in which scoring done never=0 and always=4

  12. Abbreviated physical examinations in terms of constipation for Time: minutes in lavatory per attempt

    Time frame: Baseline Day 1, Day 45 and on Day 90

    To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Time: minutes in lavatory per attempt in which scoring done Less than 5=0 and More than 30=4

  13. Abbreviated physical examinations in terms of constipation for Failure: unsuccessful attempts for evacuation per 24 hours

    Time frame: Baseline Day 1, Day 45 and on Day 90

    To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Failure: unsuccessful attempts for evacuation per 24 hours in which scoring done never=0 and More than 9 =4

  14. Abbreviated physical examinations in terms of constipation for Difficulty: painful evacuation effort

    Time frame: Baseline Day 1, Day 45 and on Day 90

    To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Difficulty: painful evacuation effort in which scoring done never=0 and always =4

  15. Abbreviated physical examinations in terms of constipation for Pain: abdominal pain

    Time frame: Baseline Day 1, Day 45 and on Day 90

    To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Pain: abdominal pain in which scoring done never=0 and always =4

  16. Abbreviated physical examinations in terms of constipation for Assistance: type of assistance

    Time frame: Baseline Day 1, Day 45 and on Day 90

    To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Assistance: type of assistance in which scoring done without assistance=0 and Digital assistance or enema =2

  17. Abbreviated physical examinations in terms of constipation for History: duration of constipation (years)

    Time frame: Baseline Day 1, Day 45 and on Day 90

    To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for History: duration of constipation (years) in which scoring done 0=0 and more than 20 =4

  18. Abbreviated physical examinations in terms of diarrhoea

    Time frame: Baseline Day 1, Day 45 and on Day 90

    To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of diarrhoeawhere score, severe diarrhea - having more than 10 loose, watery stools in a single day (24 hours). Moderate diarrhea -having more than a few but not more than 10 diarrhea stools in a day and Mild

Secondary outcomes

  1. Effectiveness by biomarkers like CRP (C reactive protein).

    Time frame: baseline Day 01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product by Biomarkers like CRP(C reactive protein)

  2. Effectiveness by biomarkers like IL-6 (Interleukin-6).

    Time frame: baseline Day 01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product by Biomarkers IL-6 (Interleukin-6)

  3. Effectiveness of the test product in terms of subject perception questionnaire where scoring by licert scale where 1 = not at all and 5=Extremely

    Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product, on Day 45 and on Day 90

    To assess the effectiveness of the test product in terms of subject perception questionnaire

  4. change in lab parameters-Hemoglobin

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters Hemoglobin

  5. change in lab parameters-Hematocrit

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters Hematocrit

  6. change in lab parameters-RBC Counts (Red Blood Corpuscle)

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters RBC Counts (Red Blood Corpuscle)

  7. change in lab parameters-MCV (Mean corpuscular volume)

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters MCV (Mean corpuscular volume)

  8. change in lab parameters-MCH (mean corpuscular hemoglobin)

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters MCH (mean corpuscular hemoglobin)

  9. change in lab parameters-MCHC (Mean corpuscular hemoglobin concentration)

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters MCHC (Mean corpuscular hemoglobin concentration)

  10. change in lab parameters-RDW (Red cell distribution width)

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters RDW (Red cell distribution width)

  11. change in lab parameters-WBC Counts (White blood cells)

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters WBC Counts (White blood cells)

  12. change in lab parameters-Neutrophils

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters Neutrophils

  13. change in lab parameters-Lymphocytes

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters Lymphocytes

  14. change in lab parameters-Eosinophils

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters Eosinophils

  15. change in lab parameters-Monocytes

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters Monocytes

  16. change in lab parameters-Basophils

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters Basophils

  17. change in lab parameters-RBC morphology

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters RBC morphology

  18. change in lab parameters-Platelet Count

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters Platelet Count

  19. change in lab parameters-Random Blood Sugar

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters Random Blood Sugar

  20. change in lab parameters-Total Serum Cholesterol

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters Total Serum Cholesterol

  21. change in lab parameters-Triglyceride

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters Triglyceride

  22. change in lab parameters-HDL (High-density lipoprotein cholesterol)

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters HDL (High-density lipoprotein cholesterol)

  23. change in lab parameters-LDL (Low-density lipoprotein)

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters LDL (Low-density lipoprotein)

  24. change in lab parameters-Serum Creatinine

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in lab parameters Serum Creatinine

  25. change in Urine Routine and Microscopy -Color

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Color

  26. change in Urine Routine and Microscopy -Transparency

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Transparency

  27. change in Urine Routine and Microscopy -Specific Gravity

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Specific Gravity

  28. change in Urine Routine and Microscopy -pH

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -pH

  29. change in Urine Routine and Microscopy -Albumin

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Albumin

  30. change in Urine Routine and Microscopy -Glucose

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Glucose

  31. change in Urine Routine and Microscopy -Bile Salts

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Bile Salts

  32. change in Urine Routine and Microscopy -Bile Pigments

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Bile Pigments

  33. change in Urine Routine and Microscopy -Bilirubin

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Bilirubin

  34. change in Urine Routine and Microscopy -Urobilinogen

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Urobilinogen

  35. change in Urine Routine and Microscopy -Ketone

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Ketone

  36. change in Urine Routine and Microscopy -Nitrite

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Nitrite

  37. change in Urine Routine and Microscopy -RBCs (Red Blood Corpuscle)

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -RBCs (Red Blood Corpuscle)

  38. change in Urine Routine and Microscopy -Leucocyte

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Leucocyte

  39. change in Urine Routine and Microscopy -WBC (White blood cell)

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -WBC (White blood cell)

  40. change in Urine Routine and Microscopy -Epithelial Cell

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Epithelial Cell

  41. change in Urine Routine and Microscopy -Casts

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Casts

  42. change in Urine Routine and Microscopy -Crystals

    Time frame: Baseline on Day -01 and after usage of the test product on Day 90.

    To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Crystals

  43. Adverse events

    Time frame: Baseline Day 1, Day 45 and on Day 90

    Safety will be determined by treatment-emergent adverse events such as allergies, diarrhoea, bloating, nausea, headache assessed by the study investigator.

Sponsors and collaborators

Lead sponsor

NovoBliss Research Pvt Ltd

Other

Collaborators

  • Meteoric Biopharmaceuticals Pvt. Ltd.

Registry information

Official study title

A Prospective, Open-label, Single-arm, Proof of Science, Clinical Safety and Efficacy Study of MetProUltima in Healthy Adult Human Subjects Having Symptoms of Gut Dysbiosis (Heart Burn, Bloating, Constipation, and Gut Immunity).

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2024
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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