Dose-Responsive Effect of Polydextrose on Whole Gut Transit Time (PDX-Transit)

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

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.

Study Overview

• Status: Terminated
• Conditions: Functional Constipation
• Intervention / Treatment: Dietary supplement: Polydextrose, low dose; Dietary supplement: Polydextrose, medium dose; Dietary supplement: Polydextrose, high dose; Dietary supplement: Placebo powder

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20089
    • Istituto Clinico Humanitas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Polydextrose, low dose	Dietary supplement: Polydextrose, low dose; 4g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
Active Comparator: Polydextrose, medium dose	Dietary supplement: Polydextrose, medium dose; 8g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
Active Comparator: Polydextrose, high dose	Dietary supplement: Polydextrose, high dose; 12g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
Placebo Comparator: Placebo powder	Dietary supplement: Placebo powder; Placebo powder will be mixed with beverage and consumed once per day for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Whole gut transit time	2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	2 weeks
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
Stool consistency	2 weeks
Degree of straining	2 weeks
Subjective assessment of bowel emptying	2 weeks
Abdominal discomfort/bloating	2 weeks
Overall product satisfaction	2 weeks
Blood and urine safety analysis	2 weeks

Collaborators and Investigators

• Sponsor: Danisco
• Collaborators: Sprim Advanced Life Sciences
• Investigators: Principal Investigator: Silvio Danese, MD, Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: February 23, 2012
• First Submitted That Met QC Criteria: February 28, 2012
• First Posted (Estimate): February 29, 2012

Study Record Updates

• Last Update Posted (Estimate): January 22, 2016
• Last Update Submitted That Met QC Criteria: January 21, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: constipation; functional constipation; whole gut transit time; polydextrose
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: Q-PRE-0111-CLI-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Terminated