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Completed

NCT Number: NCT05982743

Lactobacillus Casei Strain Shirota Fermented Milk for Alleviating Hard Stools in Vietnam

The objective of this study is to provide evidence supporting the efficacy of fermented milk containing Lactobacillus casei strain Shirota in alleviating hard or lumpy stools. A randomized, controlled trial has been designed on constipated adults with a high prevalence of hard stools in Vietnam.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bach Mai Hospital

Hanoi, 100000, Vietnam

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female or male, aged between 18 to 60 years.
  • Aware of producing hard or lumpy stools (BS score of 1 or 2) frequently.
  • Produce hard or lumpy stools (BS score of 1 or 2) ≥ 25% of bowel movements during 2 weeks of screening period.
  • Voluntarily provide written informed consent to participate in the study.

Exclusion criteria

  • Subjects whose constipation symptoms are caused by primary organic disease of the colon or pelvic floora or which, in the Investigator's opinion, is caused by medication (e.g. morphine, codeine).
  • Subjects with metabolic disorders, neurological disorders or any significant diseases or concomitant condition (e.g. abdominal/gastrointestinal surgery) that, in the investigator's opinion, would interfere with participation in the study.
  • Subjects with any known allergic reactions to any ingredients of milk.
  • Pregnant or nursing (breast-feeding) women.
  • Subjects who are unable to refrain from or anticipate the use of any medication (including laxatives, diuretics, prescription and non-prescription drugs, vitamins and herbal supplements), except for paracetamol, oral contraceptives, or hormonal replacement therapy from 2-week before the initiation of screening of subject BS score to the end of the study.
  • Subjects who are unable to refrain from or anticipate the use of any probiotics, prebiotics or yogurts from 2-week before the initiation of screening of subject BS score to the end of the study.
  • Participation in another study with Investigational product within 2 months prior to this study.
  • Drug or alcohol abuse.

Treatment and study plan

Lactobacillus casei strain Shirota fermented milk

Dietary Supplement

Participants will take one bottle (65 ml) of Yakult® drink daily, containing at least 6.5 x 10^9 CFU of Lactobacillus casei strain Shirota, for a period of 4 weeks. Subsequently, there will be a two-week follow-up period.

Primary outcomes

  1. Proportion of subjects that produce hard or lumpy stools (Bristol stool form scale (BS) score of 1 or 2) ≥ 25% of bowel movements

    Time frame: During four weeks from the date of the site visit to submit a baseline stool sample.

    Overall treatment effect during the intervention period will be estimated using mixed effects logistic regression (with a random intercept) which include "Groups (Yakult/non-treatment)", "Weeks (first/second two weeks of the intervention period)", "baseline (median BS score during baseline)" and "Gender (women/men)" as the independent variables. "Groups x Weeks" interaction will not be included because it was absent in the past RCT studies giving Yakult.

Secondary outcomes

  1. Stool frequency with hard or lumpy one (BS score of 1 or 2)

    Time frame: During four weeks from the date of the site visit to submit a baseline stool sample.

  2. Stool frequency with ideal stool (BS score of 4)

    Time frame: During four weeks from the date of the site visit to submit a baseline stool sample.

  3. Stool frequency, as measured by a daily stool diary

    Time frame: During four weeks from the date of the site visit to submit a baseline stool sample.

  4. Stool frequency with straining during evacuation, as measured by a daily stool diary (Yes/No)

    Time frame: During four weeks from the date of the site visit to submit a baseline stool sample.

  5. Stool frequency with sensation of remaining stool in the rectum after the evacuation, as measured by a daily stool diary (Yes/No)

    Time frame: During four weeks from the date of the site visit to submit a baseline stool sample.

  6. Stool frequency with sensation of anorectal blockage, as measured by a daily stool diary (Yes/No)

    Time frame: During four weeks from the date of the site visit to submit a baseline stool sample.

  7. Stool frequency with which manual maneuvers are used, as measured by a daily stool diary (Yes/No)

    Time frame: During four weeks from the date of the site visit to submit a baseline stool sample.

  8. Chinese Constipation Questionnaire score

    Time frame: During four weeks from the date of the site visit to submit a baseline stool sample.

  9. Stool microbiota (increase in the abundance of bifidobacteria)

    Time frame: During four weeks from the date of the site visit to submit a baseline stool sample.

Other outcomes

  1. BS score of the first stool after waking up (descriptive analysis)

    Time frame: During four weeks from the date of the site visit to submit a baseline stool sample.

Sponsors and collaborators

Lead sponsor

Yakult Honsha Co., LTD

Industry

Collaborators

  • Bach Mai Hospital
  • Vietnam National University

Registry information

Official study title

A Pilot Study of Using Fermented Milk Containing Lactobacillus Casei Strain Shirota (LcS) in Some Constipated Adults Having High Prevalence of Hard Stools in Vietnam

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2023
Registry last updated
Aug 14, 2023

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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