Dose-ranging Efficacy of Polydextrose Supplement on Colonic Transit Time and Symptoms in Adults With Functional Constipation

KGK Science

Status and phase: Completed; Phase 2

Conditions: Functional Constipation

Treatments: Dietary Supplement: Litesse powder containing 4 g polydextrose; Dietary Supplement: Litesse powder containing 8 g polydextrose; Dietary Supplement: Litesse powder containing 12 g polydextrose; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02314936

01-2014

Details and patient eligibility

About

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.

Enrollment: 192 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age between 18 and 70 years.

2. Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight).

3. 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).

   OR

   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).

4. 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

5. 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.

6. Consent to the study and willing to comply with study product and methods.

7. Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.

Exclusion criteria

1. Major gastrointestinal complication (e.g. Crohn's disease, colitis, celiac disease)
2. Prior abdominal surgery that in the opinion of the investigator may present a risk for the subject or confound study results.
3. 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).
4. 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.
5. Laxative use within 48 hours of screening (rescue medication allowed for intolerable symptoms during study).
6. 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.
7. Anticipated major dietary or exercise changes during the study.
8. Systemic steroid use, within 1 month before screening.
9. Eating disorder.
10. Contraindication to dairy products (e.g., intolerance to lactose or any substance in the study product).
11. History of alcohol, drug, or medication abuse.
12. Pregnant or lactating female, or pregnancy planned during study period.
13. Participation in another study with any investigational product within 60 days of screening.
14. Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.
15. Subject under administrative or legal supervision.
16. Subject who would receive more than 4500 Euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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192 participants in 4 patient groups, including a placebo group

Litesse powder containing 12 g polydextrose

Experimental group

Description:

12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks

Treatment:

Dietary Supplement: Litesse powder containing 12 g polydextrose

Litesse powder containing 8 g polydextrose

Experimental group

Description:

8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks

Treatment:

Dietary Supplement: Litesse powder containing 8 g polydextrose

Litesse powder containing 4 g polydextrose

Experimental group

Description:

4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks

Treatment:

Dietary Supplement: Litesse powder containing 4 g polydextrose

Placebo

Placebo Comparator group

Description:

Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks

Treatment:

Dietary Supplement: Placebo