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Probiotic

Probiotic, high dose for Constipation

Phase 2 & 3
Waitlist Available
Led By JoAnn Hattner, MPH, RD
Research Sponsored by Renew Life Formulas Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

Subjects will be screened and will enter a placebo-only 2-week run-in period during which constipation symptoms will be evaluated and any disallowed products (e.g. probiotics) must be discontinued. Following successful completion of the run-in period, subjects will be randomized to probiotic (high or low-dose groups) or placebo. Subjects will then consume their assigned product daily for 6 weeks. Subjects will undergo abdominal x-rays on study days 0 and 42 to assess transit time with each examination preceded by 6 days of radiopaque Sitz marker ingestion. Subject diaries will be used to collect bowel movement frequency, stool consistency, concomitant medications, and adverse events each day during the trial. Stool samples will be collected at baseline and end of study to assess fecal probiotic count. PAC-QOL, WCS, and GSRS questionnaires will be administered at baseline and day 42. 24-hour food recalls will be administered at day 0 and 42 and the following parameters will be assessed: total calories, carbohydrate, fat, protein, fiber, and liquid intake. Weekly physical activity recalls will be completed.

Eligible Conditions
  • Constipation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Whole gut transit time
Secondary outcome measures
Adverse events
Fecal probiotic count
Gastrointestinal Symptom Rating Scale (GSRS)
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Probiotic, low doseExperimental Treatment1 Intervention
Low dose Multistrain probiotic, 15 billion cfu/day
Group II: Probiotic, high doseExperimental Treatment1 Intervention
High dose Multistrain probiotic, 100 billion cfu/day
Group III: PlaceboPlacebo Group1 Intervention
Placebo

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Who is running the clinical trial?

Renew Life Formulas IncLead Sponsor
1 Previous Clinical Trials
26 Total Patients Enrolled
Sprim Advanced Life SciencesOTHER
34 Previous Clinical Trials
5,528 Total Patients Enrolled
2 Trials studying Constipation
131 Patients Enrolled for Constipation
JoAnn Hattner, MPH, RDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
120 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~6 spots leftby May 2025