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Probiotic

Test product consumption group for Constipation

Q: Is the age criterion for participation in this research limited to individuals below 20 years old?

To be considered for this clinical trial, potential participants must have reached the age of 18 but not exceeded the age of 64.

Q: What is the current number of patients undergoing treatment in this medical study?

Indeed, the information available on clinicaltrials.gov indicates that this specific clinical trial is actively seeking participants. The trial was initially posted on September 18th, 2023 and recently updated on December 27th, 2023. In total, the study aims to enroll a cohort of 50 patients from a single designated site.

Q: Are there any ongoing efforts to enroll patients in this clinical trial at the moment?

Indeed, the details provided on clinicaltrials.gov indicate that this particular study is actively seeking participants. The trial was initially posted on September 18th, 2023 and underwent its most recent update on December 27th, 2023. The research team aims to recruit a total of 50 patients from a single site.

N/A

Recruiting

Led By Dawn Beckman, MD

Research Sponsored by Yakult U.S.A. Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a smartphone supporting either iOS version 11.0 (or later) or Android version 5.0 (or later) operating software capable of downloading and running the Dieta Health app to collect study data.

≥18 and <65 years old at Visit 1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up four-week period from the start to the end of test product consumption.

Awards & highlights

Study Summary

This trial aims to determine if drinking a specific type of fermented milk every day can help reduce the number of times a person has a bowel movement with hard or lumpy stools. The trial will involve generally

Who is the study for?

This trial is for healthy US adults aged 18-64 who often have hard or lumpy stools, with a BMI of 18.5 to less than 30. Participants should eat breakfast regularly, have at least three bowel movements per week, and be able to use a smartphone app to track their data. They must agree to maintain their usual diet and limit alcohol during the study.Check my eligibility

What is being tested?

The study tests if drinking fermented milk containing LcS daily can help reduce the frequency of bowel movements that result in hard or lumpy stools among generally healthy adults experiencing constipation.See study design

What are the potential side effects?

While not explicitly listed, potential side effects may include digestive discomfort such as bloating, gas, upset stomach or changes in stool consistency due to the introduction of probiotics from the fermented milk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a smartphone that can run the Dieta Health app.

Select...

I am between 18 and 64 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ four-week period from the start to the end of test product consumption.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~four-week period from the start to the end of test product consumption.

This trial's timeline: 3 weeks for screening, Varies for treatment, and four-week period from the start to the end of test product consumption. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Difference between groups in the proportion of bowel movement having sensation of remaining stool in the rectum after evacuation.

Difference between groups in the proportion of bowel movements having straining during evacuation.

Difference between groups in the stool consistency as collected by Dieta Health application stool image analysis.

+8 more

Other outcome measures

Clustering analysis on the multivariate data and to identify distinct groups of subjects who receive benefit from the product.

Difference between groups in the Bristol stool form score of the first stool as collected by Dieta Health application stool image analysis after waking up.

Difference between groups in the fragmentation of the first stool as collected by Dieta Health application stool image analysis after waking up.

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Test product consumption groupExperimental Treatment1 Intervention

Participants will take one bottle (80 ml) of Yakult® drink daily for a period of 4 weeks. Yakult is a branded probiotic drink with 8x10^9 CFU Lacticaseibacillus paracasei strain Shirota. Subsequently, a two-week follow-up period will follow.

Group II: No Intervention groupActive Control1 Intervention

Not taking test product

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Biofortis, Merieux NutriSciencesIndustry Sponsor

8 Previous Clinical Trials

799 Total Patients Enrolled

Yakult U.S.A. Inc.Lead Sponsor

1 Previous Clinical Trials

25 Total Patients Enrolled

BioFortisOTHER

34 Previous Clinical Trials

3,772 Total Patients Enrolled

2 Trials studying Constipation

350 Patients Enrolled for Constipation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age criterion for participation in this research limited to individuals below 20 years old?

"To be considered for this clinical trial, potential participants must have reached the age of 18 but not exceeded the age of 64."

Answered by AI

What is the current number of patients undergoing treatment in this medical study?

"Indeed, the information available on clinicaltrials.gov indicates that this specific clinical trial is actively seeking participants. The trial was initially posted on September 18th, 2023 and recently updated on December 27th, 2023. In total, the study aims to enroll a cohort of 50 patients from a single designated site."

Answered by AI

Are there any ongoing efforts to enroll patients in this clinical trial at the moment?

"Indeed, the details provided on clinicaltrials.gov indicate that this particular study is actively seeking participants. The trial was initially posted on September 18th, 2023 and underwent its most recent update on December 27th, 2023. The research team aims to recruit a total of 50 patients from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of L. Paracasei Strain Shirota on Constipation in Healthy US Adults

2023. "Effect of L. Paracasei Strain Shirota on Constipation in Healthy US Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06014008.

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