Dose-ranging Efficacy of Polydextrose Supplement on Colonic Transit Time and Symptoms in Adults With Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Intervention: Litesse powder containing 12 g polydextrose; Litesse powder containing 8 g polydextrose; Litesse powder containing 4 g polydextrose; Placebo
Intervention description: 12 g polydextrose; 8 g polydextrose, 4 g maltodextrin; 4 g polydextrose, 8 g maltodextrin; 12 g Maltodextrin
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Constipation; Polydextrose; Dietary Fiber; PAC-QoL; Colonic Transit Time; PAC-SYM

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.
    

Eligibility criteria:

        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.