ISRCTN42793297Completed未知
A randomised controlled trial investigating the dose dependent effect of prunes on gastrointestinal health in adults with infrequent bowel movements
King's College London (UK)0 sites120 target enrollmentStarted: February 10, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29398337
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Adult men and women between the ages of 18 to 65 years
- •2. Adults with stool frequency of 3-6 times per week
- •3. Adults able to give informed consent
Exclusion Criteria
- •1. Regular consumption of dried fruit (based on specific screening questions)
- •2. Consumption of more than one portion of whole grain cereals per day (>1 x 80g) and more than three portions of fruit and vegetables per day (>3 x 80g) or more than five portions of fruit and vegetables per day (>5 x 80g)
- •3. Dislike of prunes
- •4. Consumption of any pre or probiotic (in food products or as supplements) in the last 4 weeks prior to, or during the study
- •5. Adults taking medications known to effect gut motility, for example prokinetic agents (such as metoclopramide, domperidone, erythromycin, azithromycin), anti-emetics agents, narcotic analgesic agents (such as methadone, fentanyl), anticholinergic agents for irritable bowel syndrome [BS], medications for constipation (including enemas, cathartics, polyethylene glycol solutions, lactulose), 5HT3 antagonists, anti-diarrheal agents (such as loperamide), opiate agents used to treat diarrhoea, non-steroidal anti-inflammatory drugs [NSAIDs] (more than once daily).
- •6. Subjects who have taken a course of antibiotics in the last 4 weeks prior to, or during the study
- •7. Subjects with any gastro-intestinal disease including IBD and coeliac disease, history of diverticulitis
- •8. Subjects with co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease likely to affect motility
- •9. Previous GI surgery, except cholecystectomy and appendectomy
- •10. Patients with neurological diseases such as multiple sclerosis, strokes, spinal cord injuries, and those who have problems with cognizance, i.e. a mini-mental score of <15 and/or are legally blind will be excluded
- •11. Patients with Hirschsprung's disease, or active local anorectal problems such as anal fissures, bleeding haemorrhoids, etc
- •12. Subjects with eating disorders
- •13. Use (more than six times in last 3 months) of laxatives, fibre supplements etc
- •14. Patients defined as having constipation or IBS based upon Rome III criteria for both
- •15. Females of childbearing age who are not practicing birth control and/or who are pregnant or lactating. (A urine pregnancy test will be performed on female participants prior to X-ray fluoroscopy)
Investigators
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