Constipation Digestive System Constipation
Conditions
Interventions
Subjects received one of the following two interventions: identical placebo or one sachet of Kivia powder, containing the active ingredient zyactinase (5,500 mg), daily for four weeks.
Eighty-seven
Sponsors
Vital Food Processors Ltd (New Zealand)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adults between 18 and 65 years of age and with a body mass index (BMI) between 20 and 35 kg/m2 2. The subjects had symptoms consistent with occasional constipation; these included at least two of the following occurring during the two-week run-in period: 2.1. Three or fewer defecations per week 2.2. Straining during at least 25% of defecations 2.3. Lumpy or hard stools in at least 25% of defecations 2.4. A sensation of incomplete evacuation for at least 25% of defecations 2.5. A sensation of anorectal obstruction or blockage for at least 25% of defecations 2.6. Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor) 3. Subjects were also required to be willing to maintain his or her habitual food and beverage intake (other than substitution of study food for similar products) and physical activity patterns throughout the study period. The subjects were judged by the investigator to be in general good health on the basis of their medical histories 4. Informed consents were signed
Exclusion criteria
Exclusion criteria: 1. Any significant gastrointestinal condition that would potentially interfere with the evaluation of the study product, including, but not limited to, inflammatory bowel disease (ulcerative colitis or Crohn?s) 2. A history of frequent diarrhea 3. A history of surgery for weight loss (including gastric bypass or lapband) 4. A history of perforation of the stomach or intestines 5. Gastroparesis, or clinically important lactose intolerance 6. Clinically significant renal, hepatic, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic, hematologic, or biliary disorders 7. Known allergy or sensitivity to kiwifruit 8. A recent (within two weeks of visit 1, week -1) episode of acute gastrointestinal illness such as nausea, vomiting, or diarrhea 9. A history or presence of cancer in the prior two years, except for nonmelanoma skin cancer 10. A recent history of (within 12 months) or a strong potential for alcohol or substance abuse 11. Participation in a clinical study with exposure to any nonregistered drug product within 30 days prior to the study 12. Any condition believed to interfere with ability to provide informed consent or comply with the study protocol, or believed to confound the interpretation of the study results or put the person at undue risk 13. Any active infection or any infection in the previous month requiring antibiotics, antiviral medication, or hospitalization 14. Diabetes requiring medication 15. Untreated or unstable hypothyroidism 16. Weight loss or gain of = 20 pounds in the previous three months 17. A clinically significant abnormal physical examination 18. An active eating disorder, including anorexia nervosa, bulimia, and/or obsessive compulsive eating disorders 19. Central neurological disorders, including, but not limited to, spinal cord injuries, multiple sclerosis, and Parkinson?s disease 20. An unwillingness to discontinue all laxatives or all dietary supplements 21. Pregnancy, lactation, or an unwillingness to use adequate contraception for the duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of Kivia powder compared to placebo on bowel movement frequency (the number of bowel movements per week) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of Kivia powder compared to placebo: 1. On gut health, including stool form (Bristol Stool Scale) 2. Bowel urgency 3. Abdominal bloating 4. Abdominal discomfort or pain 5. Satisfaction with bowel habits, flatulence and burping 6. The use of rescue medication and safety, based on adverse events Measured in daily diaries which were collected on each visit such that V1 (Screen/Run-in), V2 (Randomization) = Day 0, V3= Week 2, V4 (End of Study) = Week 4 | — |
Countries
United States of America
Outcome results
None listed