Clinical trial NCT01540669: Dose-Responsive Effect of Polydextrose on Whole Gut Transit Time
Official title: Dose-ranging Efficacy of 2-week Polydextrose Supplementation on Whole Gut Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation: A Double-blind, Randomized, Placebocontrolled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Functional Constipation
Keywords: constipation
functional constipation
polydextrose
whole gut transit time
Lead sponsor: Danisco
Sponsor class: INDUSTRY
Collaborators: name: Sprim Advanced Life Sciences
First posted: 2012-02-29
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Given the promising, yet largely unsubstantiated, benefits of fiber supplementation, particularly polydextrose, on symptoms of functional constipation, the objective of this clinical trial is to evaluate the safety and effectiveness of 2-week supplementation of a proprietary polydextrose fiber product, in a dose-ranging fashion, on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.

Eligibility criteria: Inclusion Criteria:

* 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
  * Consistent use and dose of chronic medication, if any, in the past 30 days

Exclusion Criteria:

* 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
* History of alcohol, drug, or medication abuse
* Participation in another study with any investigational product within 3 months of screening
* Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study

Primary outcomes:
measure: Whole gut transit time
timeFrame: 2 weeks
Secondary outcomes:
measure: Patient assessment of constipation quality of life
timeFrame: 2 weeks
measure: Patient assessment of constipation symptoms
timeFrame: 2 weeks
measure: Bowel Function Index
timeFrame: 2 weeks
measure: Adequate relief of constipation
timeFrame: 2 weeks
measure: Bowel movement frequency
timeFrame: 2 weeks
measure: Stool consistency
timeFrame: 2 weeks
measure: Degree of straining
timeFrame: 2 weeks
measure: Subjective assessment of bowel emptying
timeFrame: 2 weeks
measure: Abdominal discomfort/bloating
timeFrame: 2 weeks
measure: Overall product satisfaction
timeFrame: 2 weeks
measure: Blood and urine safety analysis
timeFrame: 2 weeks
measure: Adverse events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Clinico Humanitas
Study officials:
affiliation: Istituto Clinico Humanitas
name: Silvio Danese, MD
role: PRINCIPAL_INVESTIGATOR
References: