Effects of Probiotic Supplementation on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Constipation.

NCT02189707 | Completed Phase 2

• 1 other identifier: Bifido transit 3
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if Bifidobacterium lactis HN109 improves transit time and gastrointestinal symptoms in adults with constipation.

Conditions

Constipation; Gastrointestinal Disorder

Keywords

Gastrointestinal disorder; Constipation; Probiotics; Dietary supplement

Outcome Measures

Primary Outcomes (1)

• Colonic transit time

  The primary outcome of Colonic Transit Time will be evaluated with abdominal x-rays on days 0 and 28

Secondary Outcomes (10)

• Patient (syn. participant) assessment of constipation symptoms (PAC-SYM)

  At days 0 and 28

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

  At days 0 and 28

• Bowel Function Index

  At days 0 and 28

• Adequate Relief of constipation (yes/no)

  At days 0 and 28

• Bowel movement frequency stools per week)

  Participants will record the number of defecations per day in a daily diary during the 2-week run-in period and each day during the 4-week supplementation period

Study Arms (3)

Probiotic Bifidobacterium 1x1010 cfu

EXPERIMENTAL

One capsule of study product, mixed with provided yogurt, will be consumed once a day.

Dietary Supplement: Probiotic Bifidobacterium 1x1010 cfu

Probiotic Bifidobacterium 1x109 cfu

EXPERIMENTAL

One capsule of study product, mixed with provided yogurt, will be consumed once a day.

Dietary Supplement: Probiotic Bifidobacterium 1x109 cfu

Placebo powder in capsules

PLACEBO COMPARATOR

One capsule of study product, mixed with provided yogurt, will be consumed once a day.

Other: Placebo powder in capsules

Interventions

Probiotic Bifidobacterium 1x1010 cfu DIETARY_SUPPLEMENT

Participants who pass the initial screening will enter a 2-week placebo-only run-in period. Participants who successfully complete the run-in period will be randomized to daily supplementation with B. lactis HN019 (1 x 1010 cfu), B. lactis HN019 (1 x 109 cfu), or placebo for 4 weeks.

Also known as: Probiotic powder (1 x1010 cfu B. lactis HN019) in capsules

Probiotic Bifidobacterium 1x1010 cfu

Probiotic Bifidobacterium 1x109 cfu DIETARY_SUPPLEMENT

Participants who pass the initial screening will enter a 2-week placebo-only run-in period. Participants who successfully complete the run-in period will be randomized to daily supplementation with B. lactis HN019 (1 x 1010 cfu), B. lactis HN019 (1 x 109 cfu), or placebo for 4 weeks. One capsule of study product, mixed with provided yogurt, will be consumed once a day.

Also known as: Probiotic powder (1 x 109 cfu B. lactis HN019) in capsules

Probiotic Bifidobacterium 1x109 cfu

Placebo powder in capsules OTHER

Participants will consume placebo capsules only during the 2-week run-in period. After randomization, participants will be administered their assigned study product and will continue on the product for 4 weeks.

Placebo powder in capsules

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 18 to 70 years
• Body mass index between 18.5 and 34.9 kg/m2
• \. Meets the Rome III criteria for functional constipation as follows: (Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis):
• Must meet 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

You may not qualify if:

• Major gastrointestinal complication (e.g. Crohn's disease, ulcer)
• \. Prior abdominal surgery that, in the opinion of the investigator, may present a risk for the participant or confound study results
• \. Clinically significant underlying systemic illness that may preclude the participant's ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness)
• \. Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening and throughout the trial other than the provided study products
• \. Laxative use within 48 hours of screening (rescue medication allowed for intolerable symptoms during study)
• \. Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-Hydroxytryptamine#-antagonists, antacids with magnesium, calcium or aluminum, antidiarrheal medication, anticholinergic agents, calcium supplements, calcium channel blockers, tricyclic antidepressants or nonsteroidal antiinflammatory drugs), within 1 month before screening.
• \. Anticipated major dietary or exercise changes during the study
• \. Systemic steroid use, within 1 month before screening.
• \. Eating disorder
• \. Contraindication to dairy products (e.g., intolerance to lactose or any substance in the study product)
• \. History of alcohol, drug, or medication abuse
• \. Pregnant or lactating female, or pregnancy planned during study period.

Sponsors & Collaborators

• Danisco Sweeteners Oy: lead
• Eurofins Optimed: collaborator

Study Sites (1)

EUROFINS OPTIMED Clinical Research

Gières, 38610, France

Location

MeSH Terms

Conditions

Constipation; Gastrointestinal Diseases

Interventions

Capsules

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Mathilde Latreille-Barbier, MD

  Eurofins Optimed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 14, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 7, 2015

Record last verified: 2015-05

Locations

FR (1)