Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT04305535
Status:
UNKNOWN
Last Update Posted:
2020-03-12
First Post:
2020-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of an Oligomeric Diet in Intestinal Absorption and Inflammatory Markers in Patients With Crohn Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'C564245', 'term': 'Platelet Glycoprotein IV Deficiency'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 162}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-11', 'studyFirstSubmitDate': '2020-03-05', 'studyFirstSubmitQcDate': '2020-03-11', 'lastUpdatePostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Malabsorption', 'timeFrame': '6 months', 'description': 'Body Weight Change (kg)'}], 'secondaryOutcomes': [{'measure': 'Changes in the consistency of the stools according to Bristol scale.', 'timeFrame': '6 months', 'description': 'Bristol scale: type 1= separate hard lumps, type 2= sausage shaped but lumpy, type 3= like a sausage but with cracks on ots surface, type 4= like a sausage or sanake, smooth and soft, type 5= soft blobs with clear cut-edges, type 6= fluffy pieces with ragged edges, a mushy stool, type 7 = watery, no solid pieces.'}, {'measure': 'Fat malabsorption', 'timeFrame': '6 months', 'description': 'Presence of fat in the stool'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oligomeric diet', 'Peptidic diet', 'Probiotics', 'Oral Nutritional Supplements'], 'conditions': ['Crohn Disease', 'Absorption; Disorder, Protein', 'Absorption; Disorder', 'Absorption; Disorder, Fat', 'Absorption; Disorder, Carbohydrate', 'Malnutrition']}, 'descriptionModule': {'briefSummary': "This is a randomized, multicenter, translational, triple-blind, clinical trial in patients with Crohn's disease, who will be prescribed an oral nutritional supplement to control symptoms in the acute phase and to recover in the remission phase.", 'detailedDescription': 'Multicentric, parallel, randomized, double blind and controlled clinical-nutritional study of 6 months of intervention and 3 study groups of treatment: Experimental group (peptidic diet with a mix of probiotics); Experimental group with placebo (peptidic diet with a placebo); and Control group (control with a polymeric nutritional oral supplement with a placebo) to evaluate the effect on the nutritional status, inflammatory markers and the intestinal absorption'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unintentional weight loss of 5% in 6 months or a BMI less than 20kg/m2 or does not get the energy requirements with normal food.\n* Willing to comply with the prescribed diet follow-up for CD.\n\nExclusion Criteria:\n\n* Having received antibiotics in the previous 3 months\n* Having undergone intestinal resection surgery≥70-75%\n* Refuse to participate in the study\n* Comorbidity that allows to suspect survival \\<1 year'}, 'identificationModule': {'nctId': 'NCT04305535', 'briefTitle': 'Impact of an Oligomeric Diet in Intestinal Absorption and Inflammatory Markers in Patients With Crohn Disease', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz'}, 'officialTitle': 'Clinical Trial to Evaluate the Effect of an Oligomeric Oral Nutritional Supplement on the Response in Intestinal Absorption and Inflammation, in Patients With CROHN Disease', 'orgStudyIdInfo': {'id': 'EC032-19_FJD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Peptidic+Probiotic', 'description': 'Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and mix of probiotics during 6 months', 'interventionNames': ['Dietary Supplement: Peptidic+Probiotic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Peptidic+Placebo', 'description': 'Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and placebo during 6 months', 'interventionNames': ['Dietary Supplement: Peptidic+Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Polymeric+Placebo', 'description': 'Nutritional intervention and dietary recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement and placebo during 6 months', 'interventionNames': ['Dietary Supplement: Polymeric+Placebo']}], 'interventions': [{'name': 'Peptidic+Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oligomeric oral nutritional supplement (Bi1 peptidic) and a mix of probiotics\n\n* Bifidobacterium animalis subsp. lactis BPL1,\n* Lactobacillus rhamnosus BPL15,\n* Lactobacillus rhamnosus CNCM i-4036\n* Bifidobacterium longum ES1', 'armGroupLabels': ['Peptidic+Probiotic']}, {'name': 'Peptidic+Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oligomeric oral nutritional supplement (Bi1 peptidic) and a placebo', 'armGroupLabels': ['Peptidic+Placebo']}, {'name': 'Polymeric+Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Polymeric oral nutritional supplement and a placebo', 'armGroupLabels': ['Polymeric+Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Miguel A Aganzo-Yeves, RD', 'role': 'CONTACT', 'email': 'miguel.aganzo@fjd.es', 'phone': '+34661774925'}], 'facility': 'Miguel Aganzo Yeves', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Miguel A Aganzo-Yeves, RD', 'role': 'CONTACT', 'email': 'miguel.aganzo@fjd.es', 'phone': '+34661774925'}], 'overallOfficials': [{'name': 'Miguel Aganzo-Yeves, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Fundación Jiménez Díaz'}, {'name': 'Clotilde Vázquez-Martínez, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitario Fundación Jiménez Díaz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Adventia Pharma', 'class': 'INDUSTRY'}, {'name': 'Biopolis S.L.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}