Dose-ranging Efficacy of Supplementation With Polydextrose, a Dietary Fibre, on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation: A Double-blind, Randomized, Placebo-controlled Trial

KGK Science Inc.1 site in 1 country192 target enrollmentApril 2015

ConditionsFunctional Constipation

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Functional Constipation
Sponsor: KGK Science Inc.
Enrollment: 192
Locations: 1
Primary Endpoint: Change in Colonic Transit Time From Baseline to Day 15
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will investigate the effectiveness of Polydextrose, a dietary fiber, at decreasing Colonic Transit Time and the gastrointestinal symptoms of Functional Constipation. One quarter of the subjects will receive 12 g of Polydextrose daily, one quarter will receive 8 g of Polydextrose daily, one quarter will receive 4 g of Polydextrose daily and one quarter will receive a placebo daily.

Registry

clinicaltrials.gov

Start Date

April 2015

End Date

May 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

KGK Science Inc.

Responsible Party

Sponsor

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).
•If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with \> 1 year since last menstruation).
•Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
•Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System), Intrauterine devices, Double barrier method, Vasectomy of partner (shown successful as per appropriate follow-up), Tubal ligation, and Non-heterosexual lifestyle (same sex partner).
•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

Exclusion Criteria

•Major gastrointestinal complication (e.g. Crohn's disease, colitis, celiac disease)
•Prior abdominal surgery that in the opinion of the investigator may present a risk for the subject or confound study results.
•Clinically significant underlying systemic illness that may preclude the participant's ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness).
•Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening and throughout the trial other than the provided study products.
•Laxative use within 48 hours of screening (rescue medication allowed for intolerable symptoms during study).
•Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT#-antagonists, antacids with magnesium, calcium or aluminum, antidiarrheal medication, anticholinergic agents, calcium supplements, calcium channel blockers, tricyclic antidepressants or NSAIDs), within 1 month before screening.
•Anticipated major dietary or exercise changes during the study.
•Systemic steroid use, within 1 month before screening.
•Eating disorder.
•Contraindication to dairy products (e.g., intolerance to lactose or any substance in the study product).

Outcomes

Primary Outcomes

Change in Colonic Transit Time From Baseline to Day 15

Time Frame: Baseline and Day 15

Assessed using abdominal x-ray. Subjects will take 24 radiopaque markers for 6 consecutive days (144 radiopaque markers in total) immediately preceding the x-ray dates.

Secondary Outcomes

Change in Stool Frequency From Baseline to Day 15(14 day run-in and Week 2 of the 14-day supplementation period)
Change in the Bloating Severity From Baseline to Day 15(14 day run-in and Week 2 of the 14-day supplementation period)
Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15(Baseline and Day 15)
Change in Bowel Function Index From Baseline to Day 15(Baseline and Day 15)
Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15(Baseline and Day 15)
Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15(Baseline and Day 15)
Change in Stool Consistency From Baseline to Day 15(14 day run-in and Week 2 of the 14-day supplementation period)
Change in the Degree of Straining During Defecation From Baseline to Day 15(14 day run-in and Week 2 of the 14-day supplementation period)
Change in the Sensation of Complete Bowel Emptying From Baseline to Day 15(14 day run-in and Week 2 of the 14-day supplementation period)
Overall Product Satisfaction(Assessed at Day 15 (end of study))
Change in the Severity of Abdominal Discomfort From Baseline to Day 15(14 day run-in and Week 2 of the 14-day supplementation period)