protocolSection identificationModule nctId: NCT06338189, orgStudyIdInfo id: USuffolk, briefTitle: The 5Ad Diet for Functional Bowel Disorders, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-08, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Suffolk, class: OTHER, descriptionModule briefSummary: The goal of this randomised controlled trial (RCT) is to compare the efficacy of the newly developed 5Ad diet against the widely researched low fermentable oligo-, di-, monosaccharide and polyols (FODMAP) diet in reducing gastrointestinal symptoms associated with functional bowel disorders/food intolerances.The primary aims of this RCT are to determine:* Whether the 5Ad diet is at least as effective as the low FODMAP diet in reducing gastrointestinal symptoms associated with FBDs/food intolerances.* Whether either the 5Ad diet or the low FODMAP diet are effective in reducing mental and physical fatigue.To achieve the above aims, an RCT will be conducted with the 5Ad diet in one arm vs the active phase of the low FODMAP diet in the other arm, in a cross-over design with a 7 days washout phase in between. Both dietary protocols will be followed by each participant for 7 days.Researchers will compare the results from the 2 dietary protocols in order to ascertain the superiority of one over the other in regards to 6 gastrointestinal symptoms (abdominal pain, bloating, flatulence, bowel urgency, straining and incomplete defecation), stool form and frequency of defecation., conditionsModule conditions: Functional Bowel Disorder, conditions: Irritable Bowel Syndrome, conditions: Food Intolerance, conditions: Food Intolerance Syndromes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: The 5Ad Diet, interventions name: The Low FODMAP Diet, outcomesModule primaryOutcomes measure: Abdominal Pain, primaryOutcomes measure: Abdominal Bloating, primaryOutcomes measure: Flatulence, primaryOutcomes measure: Bowel Urgency, primaryOutcomes measure: Straining, primaryOutcomes measure: Incomplete Defecation, primaryOutcomes measure: Stool Form, primaryOutcomes measure: Frequency of defecation, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Mental Fatigue, secondaryOutcomes measure: Physical Fatigue, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Suffolk, status: RECRUITING, city: Ipswich, state: Suffolk, zip: IP4 1QJ, country: United Kingdom, contacts name: Camilla Bunn, role: CONTACT, phone: +44 1473 338332, email: c.bunn2@uos.ac.uk, contacts name: Dr Fandi Ibrahim, role: CONTACT, phone: +44 1473 338623, email: f.ibrahim@uos.ac.uk, contacts name: Camilla Bunn, role: PRINCIPAL_INVESTIGATOR, contacts name: Dr Fandi Ibrahim, role: SUB_INVESTIGATOR, contacts name: Dr Federica Masieri, role: SUB_INVESTIGATOR, contacts name: Martin Sinclair, role: SUB_INVESTIGATOR, geoPoint lat: 52.05917, lon: 1.15545, hasResults: False