Multistrain Probiotic for Functional Constipation

NCT01618617 | Unknown Phase 2

• 1 other identifier: 111028-SUS-REN-CTT-RA
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Constipation; Probiotic; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Whole gut transit time

  6 weeks

Secondary Outcomes (7)

• Patient Assessment of Constipation Quality of Life (PAC-QOL)

  6 weeks

• Wexner Constipation Score (WCS)

  6 weeks

• Gastrointestinal Symptom Rating Scale (GSRS)

  6 weeks

• Stool frequency

  6 weeks

• Stool consistency

  6 weeks

Study Arms (3)

Probiotic, high dose

EXPERIMENTAL

High dose Multistrain probiotic, 100 billion cfu/day

Dietary Supplement: High dose Multistrain probiotic, 100 billion cfu/day

Probiotic, low dose

EXPERIMENTAL

Low dose Multistrain probiotic, 15 billion cfu/day

Dietary Supplement: Low dose Multistrain probiotic, 15 billion cfu/day

Placebo

PLACEBO COMPARATOR

Placebo

Interventions

High dose Multistrain probiotic, 100 billion cfu/day DIETARY_SUPPLEMENT

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

Also known as: Ultimate Flora Critical

Probiotic, high dose

Low dose Multistrain probiotic, 15 billion cfu/day DIETARY_SUPPLEMENT

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

Also known as: Ultimate Flora Critical Care capsules

Probiotic, low dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Renew Life Formulas Inc: lead
• Sprim Advanced Life Sciences: collaborator

Study Sites (1)

Sprim

San Francisco, California, 94109, United States

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• JoAnn Hattner, MPH, RD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Cravotto

CONTACT

415.291.2020; karen.cravotto@sprim.com

Heather McLaughlin

CONTACT

415.291.2020; heather.mclaughlin@sprim.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 13, 2012
• Study Start: June 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 30, 2012

Record last verified: 2012-06

Locations

US (1)