Multistrain Probiotic for Functional Constipation
This study is currently recruiting participants.
Verified June 2012 by Renew Life Formulas Inc
Sponsor:
Renew Life Formulas Inc
Collaborator:
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
Renew Life Formulas Inc
ClinicalTrials.gov Identifier:
NCT01618617
First received: June 11, 2012
Last updated: November 29, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Functional Constipation |
Dietary Supplement: High dose Multistrain probiotic, 100 billion cfu/day Dietary Supplement: Low dose Multistrain probiotic, 15 billion cfu/day |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Dose-response Effectiveness of 6-week Multistrain Probiotic Supplementation on Whole Gut Transit Time, Quality of Life, and Gastrointestinal Symptoms in Adults With Functional Constipation |
Resource links provided by NLM:
Further study details as provided by Renew Life Formulas Inc:
Primary Outcome Measures:
- Whole gut transit time [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Patient Assessment of Constipation Quality of Life (PAC-QOL) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Wexner Constipation Score (WCS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Stool frequency [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Stool consistency [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Fecal probiotic count [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 81 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Probiotic, high dose
High dose Multistrain probiotic, 100 billion cfu/day
|
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).
Other Name: Ultimate Flora Critical
|
|
Experimental: Probiotic, low dose
Low dose Multistrain probiotic, 15 billion cfu/day
|
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).
Other Name: Ultimate Flora Critical Care capsules
|
|
Placebo Comparator: Placebo
Placebo
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Age 18 to 65 years
- Body mass index 18.5 to 39.9 kg/m2
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
- Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
- Able to understand the nature and purpose of the study including potential risks and side effects
- Willing to consent to study participation and to comply with study requirements
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:
- Major gastrointestinal complication (e.g. Crohn's disease, ulcer, cancer)
- Prior abdominal surgery that, in the investigator's opinion, may confound study outcomes
- Clinically significant systemic disease (e.g. cancer, diabetes, CAD)
- Consumption of probiotics or prebiotics within 2 weeks of randomization
- Antibiotic use within 4 weeks of randomization
- Laxative or other constipation medication use within 2 weeks of randomization
- Eating disorder
- Known allergies to any substance in the study product, including lactose intolerance
- Pregnant or breastfeeding women
- History of alcohol, drug, or medication abuse
- Participation in another study with any investigational product within 3 months of randomization
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618617
Contacts
| Contact: Karen Cravotto | 415.291.2020 | karen.cravotto@sprim.com |
| Contact: Heather McLaughlin | 415.291.2020 | heather.mclaughlin@sprim.com |
Locations
| United States, California | |
| Sprim | Recruiting |
| San Francisco, California, United States, 94109 | |
| Contact: Elizabeth von Dollen 415-722-0234 elizabeth.vondollen@sprim.com | |
| Principal Investigator: JoAnn Hattner, MPH, RD | |
Sponsors and Collaborators
Renew Life Formulas Inc
Sprim Advanced Life Sciences
Investigators
| Principal Investigator: | JoAnn Hattner, MPH, RD | Stanford University |
More Information
No publications provided
| Responsible Party: | Renew Life Formulas Inc |
| ClinicalTrials.gov Identifier: | NCT01618617 History of Changes |
| Other Study ID Numbers: | 111028-SUS-REN-CTT-RA |
| Study First Received: | June 11, 2012 |
| Last Updated: | November 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Renew Life Formulas Inc:
|
Constipation Probiotic Randomized Controlled Trial |
Additional relevant MeSH terms:
|
Constipation Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013