Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-29 @ 7:22 AM
Study NCT ID:
NCT05810168
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2023-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional Dietary Advice Versus Low FODMAP Diet in Postprandial Functional Dyspepsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004415', 'term': 'Dyspepsia'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2023-03-30', 'studyFirstSubmitQcDate': '2023-03-30', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of clinical responders between traditional dietary advice vs. a Low FODMAP diet on the leuven postprandial distress scale (LPDS)', 'timeFrame': '6 weeks', 'description': 'The Leuven Postprandial Distress Scale (LPDS) assesses the severity of 8 upper gastrointestinal symptoms scored from 0 (none) to 4 (very severe). A difference of 0.5 from baseline for the cardinal PDS symptoms (average of first 3 questions) will be used as a cut-off to determine clinical response by comparing average pre-treatment scores with the average score during weeks 4-6.'}], 'secondaryOutcomes': [{'measure': 'Proportion of clinical responders between traditional dietary advice vs. a low FODMAP diet', 'timeFrame': '6 weeks', 'description': 'Self-reported adequate relief of dyspeptic symptoms as a binary answer (yes or no). A responder will be defined if ≥50% adequate relief of dyspeptic symptoms during weeks 4-6'}, {'measure': 'Changes in Gastrointestinal Symptom Rating Irritable Bowel syndrome Scale', 'timeFrame': '6 weeks', 'description': 'The validated Gastrointestinal Symptom Rating Scale assesses the symptoms of irritable bowel syndrome, depicting problems with satiety, abdominal pain, diarrhoea, constipation and bloating. Higher scores represent greater symptom severity. Change in scores will be compared within- and between- groups.'}, {'measure': 'Changes in Napean Dyspepsia-related Quality of Life Index', 'timeFrame': '6 weeks', 'description': 'The Napean Dyspepsia Scale is a validated questionnaire assessing dyspepsia-related quality of life syndrome, with higher scores representing worse quality of life. Change in scores will be compared within- and between- groups'}, {'measure': 'Changes in Hospital Anxiety and Depression scale', 'timeFrame': '6 weeks', 'description': 'The Hospital Anxiety and Depression Scale is a validated questionnaire assessing mood, with higher scores representing worse mood. Change in scores will be compared within- and between- groups'}, {'measure': 'Changes in Somatic Symptom reporting', 'timeFrame': '6 weeks', 'description': 'The validated patient health questionnaire-12 assess extra-intestinal somatic symptoms, with higher scores representing greater somatic symptom severity. Change in scores will be compared within- and between- groups'}, {'measure': 'Changes in nutritional intake', 'timeFrame': '6 weeks', 'description': 'The Comprehensive Nutritional Assessment Questionnaire assesses macronutrient and micronutrient intake, FODMAPs, fibre, starch, glycaemic index/load. Change in scores will be compared within- and between- groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyspepsia', 'Functional Gastrointestinal Disorders']}, 'descriptionModule': {'briefSummary': 'Functional dyspepsia is common, affecting 7.2% of the global population, and associated with substantial health impairment. Almost 80% of patients with functional dyspepsia report meal-related symptoms and are classified as having the postprandial distress syndrome (PDS) variant. However, studies evaluating dietary modifications in PDS are sparse.\n\nThe investigators will perform a randomised trial evaluating traditional dietary advice (TDA) vs. a diet low in fermentable fermentable oligo-, di-, mono- saccharides and polyols (low FODMAP diet) in PDS.\n\n70 patients with PDS will be randomly assigned TDA or a low FODMAP diet. The TDA group will be recommended to eat small, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre. The low FODMAP diet group will be advised to exclude fermentable carbohydrates, which are present in wheat-based products, many fruits/vegetables, pulses, beans, dairy, and sweeteners.\n\nQuestionnaires are to be completed during the 6-week trial, including self-reported adequate relief of dyspeptic symptoms, and the validated Leuven Postprandial Distress Scale (LPDS), Gastrointestinal Symptom Rating Scale, and Nepean Dyspepsia Quality of Life Index.\n\nThe primary endpoint to define clinical response will be evaluated over weeks 4-6 as \\>0.5-point reduction in the PDS subscale of the LPDS (calculated as the mean scores for early satiety, postprandial fullness, and upper abdominal bloating).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fulfil Rome IV symptoms criteria for postprandial functional dyspepsia\n* Normal upper gastrointestinal endoscopy within last 3years\n* Online access\n* English literate\n\nExclusion Criteria:\n\n* Organic gastrointestinal diseases (e.g. inflammatory bowel disease, GI cancer, coeliac disease)\n* Major abdominal surgery (except laparoscopy, appendectomy, cholecystectomy)\n* Documented H.pylori in the last 3 months\n* History of eating disorders\n* Body mass index \\<20\n* Current dietary interventions\n* Current use of opioids or anti-inflammatory drugs\n* Severe systemic disease (e.g. cardiac, renal, respiratory) necessitating frequent medical consultations)\n* Pregnant\n* Diabetes mellitus\n* Scleroderma\n* Memory impairment'}, 'identificationModule': {'nctId': 'NCT05810168', 'briefTitle': 'Traditional Dietary Advice Versus Low FODMAP Diet in Postprandial Functional Dyspepsia', 'organization': {'class': 'OTHER', 'fullName': 'Sheffield Teaching Hospitals NHS Foundation Trust'}, 'officialTitle': 'Randomised Trial of Traditional Dietary Advice Versus a Low FODMAP Diet in Postprandial Functional Dyspepsia', 'orgStudyIdInfo': {'id': 'STH20655c'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Dietary Advice', 'description': 'Recommended to eat smaller, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre', 'interventionNames': ['Other: Dietary modifications']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low FODMAP diet', 'description': 'FODMAPs are fermentable carbohydrates that increase intestinal water and gas production that, in those with visceral hypersensitivity, induces gastrointestinal symptoms. The low FODMAP diet therefore excludes fermentable carbohydrates, which are present in wheat-based products, many fruits/vegetables, pulses, beans, dairy, and sweeteners.', 'interventionNames': ['Other: Dietary modifications']}], 'interventions': [{'name': 'Dietary modifications', 'type': 'OTHER', 'description': 'TDA and low FODMAP diet', 'armGroupLabels': ['Low FODMAP diet', 'Traditional Dietary Advice']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S10 2JF', 'city': 'Sheffield', 'state': 'South Yorkshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Jemima Clarke', 'role': 'CONTACT', 'email': 'sth.researchadministration@nhs.net', 'phone': '01142265943'}, {'name': 'Imran Aziz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Hallamshire Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}