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OpenTrials
Completed

NCT Number: NCT06738433

Efficacy and Tolerability of ABB I5 Prebiotic and ABB C22 Postbiotics for the Management of Constipation and Gastrointestinal Well-being: a Pilot Trial

In this study, we aim at assessing the benefits of dietary supplementation with ABB i5 and ABB C24, a combination of the the prebiotic ABB i5 and the postbiotic ABB C22, on the gut microbiota of people with constipation and on their gastrointestinal well-being.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Isabel Roig

Barcelona, 08030, South Sudan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects who require hospitalization
  • Constipation defined as the Rome IV criteria for constipation
  • Patients with the ability to take the study product orally

Exclusion criteria

  • History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or to any of the excipients.
  • History or evidence of any medical conditions or medication used that, in the opinion of the principal investigator, could affect the safety of the subjects or interfere with the study evaluations
  • Patients last palliative care en stage of "end of life" or "terminal"
  • Amytriptilin (anti-depressive) and masalazine (anti-inflammatory) treatment
  • Laxatives
  • Antibiotic treatment in the previous 2 weeks
  • Patients with IBS or any other gastrointestinal conditions that maybe the cause of the constipation

Treatment and study plan

ABB i5

Dietary Supplement

Prebiotic ABB i5 (NextDext®, 5g)

ABB C24

Dietary Supplement

ABB C24: Prebiotic ABB i5 (NextDext®, 5g) + yeast postbiotic ABB C22 (200 mg) in sachets containing 5,2 g

Primary outcomes

  1. Microbiota composition

    Time frame: from baseline to day 14 of supplementation

    Changes in microbiota composition through Shanon diversity test and statistical analyses (Continuous variables will be described as mean and standard deviation (SD) or as median and interquartile range; and categorical variables such as absolute frequencies and percentages).

Secondary outcomes

  1. Transit time

    Time frame: from baseline to day 14 of supplementation

    transit time measured as methane on breathe testing

  2. Tolerance and gastro-intestinal comfort

    Time frame: from baseline to day 14 of supplementation

    Tolerance and gastro-intestinal comfort (validated questionnaires) life questionnaire: the Digestion-associated Quality of Life Questionnaire (DQLQ)

  3. Brain Derived Neurotrophic Factor (BDNF)

    Time frame: from baseline to day 14 of supplementation

    levels of Brain Derived Neurotrophic Factor (BDNF) (pg/mL)

Sponsors and collaborators

Lead sponsor

AB Biotek

Industry

Collaborators

  • Grupo Colisée

Registry information

Acronym: ABB i5/ABB C24

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

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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