Dose-Responsive Effect of Polydextrose on Whole Gut Transit Time

NCT01540669 | Terminated

• 1 other identifier: Q-PRE-0111-CLI-007
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to test the effect of polydextrose on whole gut transit time and gastrointestinal symptoms in a dose-responsive manner.

Conditions

Functional Constipation

Keywords

constipation; functional constipation; polydextrose; whole gut transit time

Outcome Measures

Primary Outcomes (1)

• Whole gut transit time

  2 weeks

Secondary Outcomes (12)

• Patient assessment of constipation quality of life

  2 weeks

• Patient assessment of constipation symptoms

  2 weeks

• Bowel Function Index

  2 weeks

• Adequate relief of constipation

  2 weeks

• Bowel movement frequency

  2 weeks

Study Arms (4)

Polydextrose, low dose

ACTIVE COMPARATOR

Polydextrose, low dose

Dietary Supplement: Polydextrose, low dose

Polydextrose, medium dose

ACTIVE COMPARATOR

Polydextrose, medium dose

Dietary Supplement: Polydextrose, medium dose

Polydextrose, high dose

ACTIVE COMPARATOR

Polydextrose, high dose

Dietary Supplement: Polydextrose, high dose

Placebo powder

PLACEBO COMPARATOR

Placebo powder

Dietary Supplement: Placebo powder

Interventions

Polydextrose, low dose DIETARY_SUPPLEMENT

4g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks

Polydextrose, low dose

Polydextrose, medium dose DIETARY_SUPPLEMENT

8g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks

Polydextrose, medium dose

Polydextrose, high dose DIETARY_SUPPLEMENT

12g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks

Polydextrose, high dose

Placebo powder DIETARY_SUPPLEMENT

Placebo powder will be mixed with beverage and consumed once per day for 2 weeks

Placebo powder

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 between 18 and 70 years
• Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight)
• 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
• Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects
• Consent to the study and willing to comply with study product and methods
• Willingness to maintain a stable diet throughout the study

You may not qualify if:

• Major gastrointestinal complication (e.g. Crohn"s disease, colitis, celiac disease)
• Febrile diverticulitis within 1 year of screening
• Pelvic floor dysfunction
• Prior abdominal surgery that in the opinion of the investigator may present a risk for the subject or confound study results
• Prior abdominal surgery of the following type: gastric bypass, lap band, colectomy, removal of gall bladder
• Clinically significant underlying systemic illness that may preclude the subject"s ability to complete the trial or that may confound the study outcomes
• Any clinically relevant abnormalities in the physical examination or in laboratory variables before entry into the study
• Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening
• Laxative, fiber supplement, or other constipation medication (e.g. prokinetic drugs) use within 2 weeks of screening
• Antibiotic use within 1 month of enrollment
• Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT#- antagonists, antacids with magnesium or aluminum, or diarrhea medication)
• Anticipated major dietary or exercise changes during the study period
• Known allergies to any substance in the study product
• Pregnant or lactating female, or pregnancy planned during study period
• Eating disorder

Sponsors & Collaborators

• Danisco: lead
• Sprim Advanced Life Sciences: collaborator

Study Sites (1)

Istituto Clinico Humanitas

Milan, 20089, Italy

Location

MeSH Terms

Conditions

Constipation

Interventions

polydextrose

Condition Hierarchy (Ancestors)

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

Study Officials

• Silvio Danese, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: February 29, 2012
• Study Start: March 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 22, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)