Clinical trial NCT02314936: Dose-ranging Efficacy of Polydextrose Supplement on Colonic Transit Time and Symptoms in Adults With Functional Constipation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Functional Constipation
Keywords: Constipation
Polydextrose
Dietary Fiber
PAC-QoL
Colonic Transit Time
PAC-SYM
Lead sponsor: KGK Science Inc.
Sponsor class: INDUSTRY
Collaborators: name: DuPont Nutrition and Health
First posted: 2014-12-11
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Change in Colonic Transit Time From Baseline to Day 15
timeFrame: Baseline and Day 15
Secondary outcomes:
measure: Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15
timeFrame: Baseline and Day 15
measure: Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15
timeFrame: Baseline and Day 15
measure: Change in Bowel Function Index From Baseline to Day 15
timeFrame: Baseline and Day 15
measure: Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15
timeFrame: Baseline and Day 15
measure: Change in Stool Frequency From Baseline to Day 15
timeFrame: 14 day run-in and Week 2 of the 14-day supplementation period
measure: Change in Stool Consistency From Baseline to Day 15
timeFrame: 14 day run-in and Week 2 of the 14-day supplementation period
measure: Change in the Degree of Straining During Defecation From Baseline to Day 15
timeFrame: 14 day run-in and Week 2 of the 14-day supplementation period
measure: Change in the Sensation of Complete Bowel Emptying From Baseline to Day 15
timeFrame: 14 day run-in and Week 2 of the 14-day supplementation period
measure: Change in the Severity of Abdominal Discomfort From Baseline to Day 15
timeFrame: 14 day run-in and Week 2 of the 14-day supplementation period
measure: Change in the Bloating Severity From Baseline to Day 15
timeFrame: 14 day run-in and Week 2 of the 14-day supplementation period
measure: Overall Product Satisfaction
timeFrame: Assessed at Day 15 (end of study)
Other outcomes:
measure: Change in Hemoglobin Levels From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Hematocrit Levels From Screening to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in White Blood Cell Count From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Red Blood Cell Count From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Mean Corpuscular Volume From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Mean Corpuscular Hemoglobin From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Mean Corpuscular Hemoglobin Concentration From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Red Cell Distribution Width From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Platelet Count From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Neutrophil Count From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Lymphocyte Count From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Monocyte Count From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Eosinophil Count From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Basophil Count From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Serum Glucose Concentration From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Creatinine Levels in Blood From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Serum Urea Concentration From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Serum Estimated Globular Filtration Rate From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Serum Sodium Concentration From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Serum Potassium Concentration From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Serum Chloride Concentration From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Serum Calcium Concentration From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Serum Carbon Dioxide Concentration From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Serum Phosphate Concentration From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Serum Bilirubin Concentration From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Serum Aspartate Transaminase Concentration From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Serum Alanine Transaminase Concentration From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Serum Alkaline Phosphate Concentration From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Serum Gamma-Glutamyltransferase Concentration From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Serum C-Reactive Protein Concentration From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in Specific Gravity Urinalysis Parameter From Screening to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Change in pH Urinalysis Parameter From Baseline to Day 15
timeFrame: Screening and Day 15 (end of study)
measure: Number of Subjects With Adverse Events
timeFrame: 14 days run-in and 14 days treatment
Locations:
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: Tetyana Pelipyagina, MD
role: PRINCIPAL_INVESTIGATOR
References: