The effect of fibre and fluids on gut health in adults

Not Applicable

Completed

• Conditions: Gastrointestinal health; Digestive System

• Registration Number: ISRCTN42793297
• Lead Sponsor: King's College London (UK)

Brief Summary

2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29398337

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-10
• Study Completion: 2012-10-01
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Difference in stool weight and frequency of bowel movement between the three study arms at the end of the intervention, as determined by a 7 day total stool collection at baseline and at the end of the intervention <br>2. Stool and symptom diary completed at baseline, two weeks, end of intervention and four week follow-up, respectively