Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT06460805
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in Axial Spondyloarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D064806', 'term': 'Dysbiosis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D025241', 'term': 'Spondylarthritis'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-13', 'studyFirstSubmitDate': '2024-06-05', 'studyFirstSubmitQcDate': '2024-06-13', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in faecal butyrate at 2 weeks on a PEN diet', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Partial Enteral Nutrition', 'Nutrition', 'Axial spondyloarthritis', 'Ankylosing spondylitis', 'axSpA', 'Diet', 'PEN', 'AS'], 'conditions': ['Axial Spondyloarthritis', 'Ankylosing Spondylitis', 'Inflammation', 'Dysbiosis', 'Arthritis', 'Spondylitis', 'Spondylarthritis', 'SpA', 'AxSpA']}, 'descriptionModule': {'briefSummary': "People with axial spondyloarthritis (axSpA) often have intestinal inflammation and intestinal microbiome dysbiosis, with some similarities to Crohn's-like inflammatory bowel disease (IBD) gut inflammation. However, research has not addressed whether Partial Enteral Nutrition (PEN), a diet formed of a liquid formula and some solid whole foods, which is effective at inducing remission in IBD, may influence the dysbiotic microbiome and inflamed, hyperpermeable intestine of axSpA patients, and whether these changes may be accompanied by alterations in systemic markers of inflammation. Thus, there is a need to determine the effects of PEN on these aspects in axSpA patients.\n\nIn this study, the investigators intend to trial a 2-week course (with optional additional 2-week extension) of a PEN diet in people with active axSpA disease. A group of healthy volunteers following the same diet will act as a control."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Eligibility Criteria for Participants with axSpA\n\nInclusion criteria. Participants will fulfil ALL of the following:\n\n* Diagnosis of axSpA (fulfilling the ASAS criteria)\n* Active disease (BASDAI score ≥4) on day of study visit\n* Stable on treatment \\[defined as (1) no major change to therapy (change in treatment type) in the preceding 3 months AND (2) no minor change in therapy (adjustment of treatment dosage) in the preceding 1 month\\]\n* Age ≥ 16 years\n* Willing and able to give informed written consent.\n\nExclusion. Participants will have NONE of the following:\n\n* Pregnancy or breastfeeding\n* Prior diagnosis of IBD\n* Recipient of chemotherapy/immunotherapy/radiotherapy in prior 3 months\n* Recent systemic antibiotic use (within last 1 month)\n* Current eating disorder\n* Food allergy incompatible with diet (e.g. cow's milk allergy)\n* Following a vegan diet\n* Major surgery in prior 3 months or planned in forthcoming 3 months.\n* Unable or unwilling to give informed consent\n* Unable or unwilling to try the PEN diet.\n\nEligibility Criteria for Healthy Volunteer Participants\n\nInclusion criteria. Participants will fulfil ALL of the following:\n\n* Age ≥ 16 years\n* Current student and/or staff member at the University of Glasgow\n* Willing and able to give informed written consent\n\nExclusion. Participants will have NONE of the following:\n\n* Pregnancy or breastfeeding\n* Prior diagnosis of an immune-mediated inflammatory condition\n* Recipient of chemotherapy/immunotherapy/radiotherapy in prior 3 months\n* Recent systemic antibiotic use (within last 1 month)\n* Current eating disorder\n* Food allergy incompatible with diet (e.g. cow's milk allergy)\n* Following a vegan diet\n* Major surgery in prior 3 months or planned in forthcoming 3 months.\n* Unable or unwilling to give informed consent\n* Unable or unwilling to try the PEN diet."}, 'identificationModule': {'nctId': 'NCT06460805', 'acronym': 'axSEND', 'briefTitle': 'axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in Axial Spondyloarthritis', 'organization': {'class': 'OTHER', 'fullName': 'NHS Greater Glasgow and Clyde'}, 'officialTitle': 'axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in People With Axial Spondyloarthritis', 'orgStudyIdInfo': {'id': 'GN23RH450'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Axial Spondyloarthritis', 'interventionNames': ['Dietary Supplement: Partial enteral nutrition']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Volunteers', 'interventionNames': ['Dietary Supplement: Partial enteral nutrition']}], 'interventions': [{'name': 'Partial enteral nutrition', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['PEN'], 'description': '70% caloric intake from enteral nutrition formula and 30% caloric intake from a limited range of solid foods', 'armGroupLabels': ['Axial Spondyloarthritis', 'Healthy Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Stefan Siebert', 'role': 'CONTACT', 'email': 'stefan.siebert@glasgow.ac.uk', 'phone': '00441413303375'}, {'name': 'Stefan Siebert', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NHS Greater Glasgow and Clyde', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Stefan Siebert', 'role': 'CONTACT', 'email': 'stefan.siebert@glasgow.ac.uk', 'phone': '00441413303375'}, {'name': 'Stefan Siebert', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Simon Milling', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rumaisa Zubairi', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Glasgow', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'centralContacts': [{'name': 'Stefan Siebert', 'role': 'CONTACT', 'email': 'stefan.siebert@glasgow.ac.uk', 'phone': '00441413303375'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Glasgow', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}