Functional Constipation | Multistrain Probiotic for Functional Constipation
Functional Constipation research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: 1. Age 18 to 65 years 2. Body mass index 18.5 to 39.9 kg/m2 3. Meets the criteria below over the last 3 months with symptom onset at least 6 months prior (Rome III definition of functional constipation 1): - Meets 2 or more of the following criteria: - Straining during at least 25% of defecations - Lumpy or hard stools in at least 25% of defecations - Sensation of incomplete evacuation for at least 25% of defecations - Sensation of anorectal obstruction/blockage for at least 25% of defecations - Manual maneuvers to facilitate at least 25% of defecations (e.g. digital evacuation, support of the pelvic floor) - Fewer than three defecations per week - Loose stools are rarely present without the use of laxatives - Insufficient criteria for irritable bowel syndrome 4. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only) 5. Able to understand the nature and purpose of the study including potential risks and side effects 6. Willing to consent to study participation and to comply with study requirements 7. Successful completion of 2-week run-in period, defined as: - Must meet the Rome III definition of functional constipation during this 2-week period - Completion of all study-related questionnaires Exclusion Criteria: 1. Major gastrointestinal complication (e.g. Crohn's disease, ulcer, cancer) 2. Prior abdominal surgery that, in the investigator's opinion, may confound study outcomes 3. Clinically significant systemic disease (e.g. cancer, diabetes, CAD) 4. Consumption of probiotics or prebiotics within 2 weeks of randomization 5. Antibiotic use within 4 weeks of randomization 6. Laxative or other constipation medication use within 2 weeks of randomization 7. Eating disorder 8. Known allergies to any substance in the study product, including lactose intolerance 9. Pregnant or breastfeeding women 10. History of alcohol, drug, or medication abuse 11. Participation in another study with any investigational product within 3 months of randomization 12. Any condition that could, in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Dietary Supplement:High dose Multistrain probiotic, 100 billion cfu/day100 billion cfu live bacteria (60 billion cfu bifidobacterium cultures and 40 billion lactobacillus cultures).
Dietary Supplement:Low dose Multistrain probiotic, 15 billion cfu/day15 billion cfu live bacteria (9 billion cfu bifidobacterium cultures and 6 billion lactobacillus cultures).
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Probiotic, high doseHigh dose Multistrain probiotic, 100 billion cfu/day
Probiotic, low doseLow dose Multistrain probiotic, 15 billion cfu/day
Start Date: June 2012
Completed Date: March 2013
Phase: Phase 2/Phase 3
Primary Outcome: Whole gut transit time
Secondary Outcome: Patient Assessment of Constipation Quality of Life (PAC-QOL)
Study sponsors, principal investigator, and references
Principal Investigator: JoAnn Hattner, MPH, RD
Lead Sponsor: Renew Life Formulas Inc
Collaborator: Sprim Advanced Life Sciences