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Behavioural Intervention

Nutrition Coaching + Supplements for Gut Microbiome Health

N/A

Recruiting

Led By Charles Baum, MD

Research Sponsored by Persephone Biosciences

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

Study Summary

This trial will test the impact of diet changes and/or a daily supplement on diet quality and gut health in 400 adults.

Who is the study for?

Healthy adults aged 18-64 who speak and write English, can provide stool samples, are willing to undergo online nutrition coaching or take a daily prebiotic/probiotic supplement for 4 months. Excluded are those with certain diseases like HIV, Hepatitis, bowel disorders, recent cancer treatments or infections; those treated for diabetes; recent antibiotic/probiotic users; participants in other dietary studies; pregnant/nursing women.Check my eligibility

What is being tested?

The trial is testing the effects of diet changes and a daily prebiotic/probiotic supplement on gut health. Participants will be divided into four groups: one control group, one with nutritional coaching, one taking supplements, and one doing both. Stool samples will be analyzed before and after the intervention.See study design

What are the potential side effects?

Potential side effects from the prebiotic/probiotic supplements may include digestive discomfort such as bloating or gas. Nutritional counseling should not have direct physical side effects but could lead to changes in diet that might affect digestion.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Nutrition Counseling Microbiome Impact

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Medical Nutrition TherapyExperimental Treatment1 Intervention

Group II: No Directed Dietary InterventionActive Control1 Intervention

Control group without any directed dietary modifications

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nutrition Counseling

2015

Completed Phase 2

~320

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kroger HealthUNKNOWN

Persephone BiosciencesLead Sponsor

4 Previous Clinical Trials

5,545 Total Patients Enrolled

Charles Baum, MDPrincipal InvestigatorIndependent

1 Previous Clinical Trials

64 Total Patients Enrolled

Frequently Asked Questions

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

Are individuals aged 40+ eligible for participation in this research experiment?

"As outlined in the study's criteria, only adults aged between 18 and 24 are allowed to join this trial."

Answered by AI

Am I eligible to partake in this investigation?

"The trial requires the enrolment of 400 participants between 18 and 24 years old, whose diet has an effect on their gut microbiome."

Answered by AI

Is this study still taking on new participants?

"According to the data provided on clinicaltrials.gov, this clinical trial has stopped recruiting patients. Initially posted in October 15th 2023 and recently modified on October 18th 2023, it is no longer accepting participants; however, there are currently 1 other trials actively looking for candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ambrosia: Evaluating the Effects of a Food-As-Medicine Platform on Gut Microbiome Composition and Metabolism

2023. "Ambrosia: Evaluating the Effects of a Food-As-Medicine Platform on Gut Microbiome Composition and Metabolism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06091813.