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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Danisco.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
Danisco
ClinicalTrials.gov Identifier:
NCT01540669
First received: February 23, 2012
Last updated: November 13, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Functional Constipation
Dietary Supplement: Polydextrose, low dose
Dietary Supplement: Polydextrose, medium dose
Dietary Supplement: Polydextrose, high dose
Dietary Supplement: Placebo powder

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Danisco:

Primary Outcome Measures:
  • Whole gut transit time [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient assessment of constipation quality of life [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Patient assessment of constipation symptoms [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Bowel Function Index [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Adequate relief of constipation [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Bowel movement frequency [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Stool consistency [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Degree of straining [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Subjective assessment of bowel emptying [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Abdominal discomfort/bloating [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Overall product satisfaction [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Blood and urine safety analysis [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 184
Study Start Date: March 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Polydextrose, low dose
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
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
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
Placebo powder
Dietary Supplement: Placebo powder
Placebo powder will be mixed with beverage and consumed once per day for 2 weeks

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540669

Contacts
Contact: Silvia Lazzati 02 45495838 silvia.lazzati@sprim.com

Locations
Italy
Istituto Clinico Humanitas Recruiting
Milan, Italy, 20089
Contact: Silvio Danese, MD       silvio.danese@humanitas.it   
Principal Investigator: Silvio Danese, MD         
Sponsors and Collaborators
Danisco
Sprim Advanced Life Sciences
Investigators
Principal Investigator: Silvio Danese, MD Istituto Clinico Humanitas
  More Information

No publications provided

Responsible Party: Danisco
ClinicalTrials.gov Identifier: NCT01540669     History of Changes
Other Study ID Numbers: Q-PRE-0111-CLI-007
Study First Received: February 23, 2012
Last Updated: November 13, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Danisco:
constipation
functional constipation
polydextrose
whole gut transit time

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 22, 2014