A low FODMAP diet for diarrhoea predominant functional gastrointestinal disorders in neuroendocrine tumour patients

Not Applicable

Completed

• Conditions: Diarrhoea predominant functional gastrointestinal disorders in pancreatic and mid gut neuroendocrine tumour patients; Digestive System

• Registration Number: ISRCTN36702813
• Lead Sponsor: The Royal Free Hospital (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-11
• Study Completion: 2018-12-31
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Adult patients who have diarrhoea predominant functional gastrointestinal disorder in the following susceptible groups:
1. Non-functioning small bowel NETs who have never had any treatment
2. Functioning small bowel NET patients on symptom controlling treatment which is not thought to be causing diarrhoea. These patients should be on a stable dose of somatostatin analogues and/or pancreatic enzyme replacement therapy for at least 3 months
3. Small bowel NET patients who are at least 3 months post intestinal surgery/injury/radiotherapy, chemotherapy PRRT, molecular targeted therapy (sunitunib, everolimus) or interferon
4. Pancreatic NET patients who have undergone the whipples operation with small bowel involvement and are at least 3 months post surgery
5. Smaller pancreatic functioning NET patients who have stable disease on somatostatin analogues

Exclusion Criteria

Patients must NOT have:
1. Diarrhoea directly related to uncontrolled hormone secretion of the tumour
2. Steatorrhoea due to insufficient pancreatic enzyme use (starting dose is 25,000 units lipase per meal, titrated up to 75,000-80,000 units lipase per meal)
3. Bile salt malabsorption
4. Short bowel syndrome
5. Any gastrointestinal disease other than a NET
6. Have constipation as the predominant symptom
7. Bacterial overgrowth in the past 4 weeks
8. Been on antibiotics in the past 4 weeks
9. Been on any lactulose, prebiotic or probiotic in the past 4 weeks
10. Had changes to any IBS medication in the past 4 weeks
11. Have had bowel preparation or investigative procedures in the past 4 weeks
12. Be pregnant or lactating
13. Diabetes, current eating disorders or psychiatric illness
14. A poor level of English skills

Study & Design

• Study Type: Interventional
• Study Design: Not specified