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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

February 23, 2012
November 13, 2012
March 2012
May 2013   (final data collection date for primary outcome measure)
Whole gut transit time [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01540669 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Dose-Responsive Effect of Polydextrose on Whole Gut Transit Time
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Functional Constipation
  • Dietary Supplement: Polydextrose, low dose
    4g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
  • Dietary Supplement: Polydextrose, medium dose
    8g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
  • Dietary Supplement: Polydextrose, high dose
    12g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
  • Dietary Supplement: Placebo powder
    Placebo powder will be mixed with beverage and consumed once per day for 2 weeks
  • Active Comparator: Polydextrose, low dose
    Polydextrose, low dose
    Intervention: Dietary Supplement: Polydextrose, low dose
  • Active Comparator: Polydextrose, medium dose
    Polydextrose, medium dose
    Intervention: Dietary Supplement: Polydextrose, medium dose
  • Active Comparator: Polydextrose, high dose
    Polydextrose, high dose
    Intervention: Dietary Supplement: Polydextrose, high dose
  • Placebo Comparator: Placebo powder
    Placebo powder
    Intervention: Dietary Supplement: Placebo powder
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
184
September 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact: Silvia Lazzati 02 45495838 silvia.lazzati@sprim.com
Italy
 
NCT01540669
Q-PRE-0111-CLI-007
No
Danisco
Danisco
Sprim Advanced Life Sciences
Principal Investigator: Silvio Danese, MD Istituto Clinico Humanitas
Danisco
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP