Multistrain Probiotic for Functional Constipation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Renew Life Formulas Inc.
Recruitment status was  Recruiting
Sponsor:
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
  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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014