Diarrhoea predominant functional gastrointestinal disorders in pancreatic and mid gut neuroendocrine tumour patients Digestive System
Conditions
Interventions
Low FODMAP diet group: complete a 4-week dietary intervention
Standard treatment group: are given a Nutrition in NETs booklet only
Sponsors
The Royal Free Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of diarrhoea, measured using the Bristol Stool Chart and the NET21 quality of life questionnaire at baseline and 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Weight, measured using weighing scales 2. Quality of life, measured by the QLQ C-30 and NET21 Quality of life questionnaires All outcomes are measured at baseline and 4 weeks. | — |
Countries
United Kingdom
Outcome results
None listed