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

NCT05982743 | Completed

• 1 other identifier: YAK-VN-001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Constipation

Outcome Measures

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

  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.

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

Secondary Outcomes (9)

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

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

• Stool frequency with ideal stool (BS score of 4)

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

• Stool frequency, as measured by a daily stool diary

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

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

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

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

  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)

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

Study Arms (2)

Fermented milk drink

EXPERIMENTAL

Dietary Supplement: Lactobacillus casei strain Shirota fermented milk

No drink

NO INTERVENTION

Interventions

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.

Fermented milk drink

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yakult Honsha Co., LTD: lead
• Bach Mai Hospital: collaborator
• Vietnam National University: collaborator

Study Sites (1)

Bach Mai Hospital

Hanoi, 100000, Vietnam

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vinh Van Hoang, PhD

  Vietnam National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 9, 2023
• Study Start: May 11, 2022
• Primary Completion: March 8, 2023
• Study Completion: March 8, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)