Dose-Responsive Effect of Polydextrose on Whole Gut Transit Time (PDX-Transit)

This is an interventional treatment trial for Functional Constipation focused on measuring constipation, functional constipation, polydextrose, whole gut transit time Read More

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