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Multistrain Probiotic for Functional Constipation

NCT01618617 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2012-11-30

No results posted yet for this 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.

Conditions

  • Functional Constipation

Interventions

DIETARY_SUPPLEMENT

High dose Multistrain probiotic, 100 billion cfu/day

100 billion cfu live bacteria (60 billion cfu bifidobacterium cultures and 40 billion lactobacillus cultures).

DIETARY_SUPPLEMENT

Low dose Multistrain probiotic, 15 billion cfu/day

15 billion cfu live bacteria (9 billion cfu bifidobacterium cultures and 6 billion lactobacillus cultures).

Sponsors & Collaborators

  • Sprim Advanced Life Sciences

    collaborator OTHER

  • Renew Life Formulas Inc

    lead INDUSTRY

Principal Investigators

  • JoAnn Hattner, MPH, RD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01618617 on ClinicalTrials.gov