Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-03-11 @ 11:21 AM
Study NCT ID:
NCT06438068
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-16
First Post:
2024-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Modern Colon Hydrotherapy on Intestinal Transit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2024-05-26', 'studyFirstSubmitQcDate': '2024-05-26', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intestinal transit', 'timeFrame': '7 days', 'description': 'intestinal transit using radiopaque markers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['constipation', 'internal hydrotherapy', 'Radiopaque Media', 'Functional Colonic Diseases'], 'conditions': ['Constipation - Functional', 'Hydrotherapy', 'Functional Colonic Diseases']}, 'descriptionModule': {'briefSummary': 'A randomised and controlled trial, in which the effect of Modern Colon Hydrotherapy is evaluated in the gastrointestinal transit of subjects with functional constipation', 'detailedDescription': 'The aim of the present randomized randomised and controlled trial is to evaluate the effect of Modern Colon Hydrotherapy in the gastrointestinal transit of subjects with functional constipation.\n\nTwo intervention groups were used, to which this type of treatment was applied and to which the intake of a product with prebiotic and prebiotic properties or a placebo was added, depending on the assigned group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 20 and 60 years of age with functional constipation of more than 5 years of evolution.\n\nExclusion Criteria:\n\n* Taking any type of antibiotic in the last month\n* Taking prebiotics or probiotics products in the last month.\n* Taking laxatives in the last month.\n* Undergoing any medicinal treatment\n* Pregnancy\n* Subject with a history of current gastrointestinal pathology or disorder such as: acute colon pathology, acute haemorrhagic colitis, suspected digestive perforation, recent abdominal surgery, severe arterial hypertension, abdominal hernia, colon neoplasia, history of cardiac syncope, renal failure, liver cirrhosis, epilepsy, severe psychiatric illness (psychosis), necrosis due to abdominal irradiation, severe anaemia, severe neurovegetative lability.'}, 'identificationModule': {'nctId': 'NCT06438068', 'briefTitle': 'Influence of Modern Colon Hydrotherapy on Intestinal Transit', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Influence of Modern Colon Hydrotherapy on Intestinal Transit', 'orgStudyIdInfo': {'id': 'UComplutenseMadrid Fasisifer3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modern Colon Hydrotherapy plus probiotic product intake', 'description': 'Colonic cleansing through 3 interventions of Modern Colon Hydrotherapy. In addition, a daily intake of a product with prebiotic and prebiotic properties for 30 days.', 'interventionNames': ['Other: Modern Colon Hydrotherapy plus probiotic product intake']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Modern Colon Hydrotherapy plus placebo intake', 'description': 'Colonic cleansing through 3 interventions of Modern Colon Hydrotherapy. In addition, a daily intake of a placebo for 30 days.', 'interventionNames': ['Other: Modern Colon Hydrotherapy plus probiotic product intake']}], 'interventions': [{'name': 'Modern Colon Hydrotherapy plus probiotic product intake', 'type': 'OTHER', 'description': 'Colonic cleansing through 3 interventions of Modern Colon Hydrotherapy separated by 48 hours. In addition, a daily intake of a product with prebiotic and prebiotic properties for 30 days.', 'armGroupLabels': ['Modern Colon Hydrotherapy plus placebo intake', 'Modern Colon Hydrotherapy plus probiotic product intake']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Isidro Fernández-López, PhD.', 'role': 'CONTACT', 'email': 'isidro.fernandez.lopez@gmail.com', 'phone': '+34625598970'}, {'name': 'David Granizo-Bermejo, Mr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universidad Complutense de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Isidro Fernández-López, PhD.', 'role': 'CONTACT', 'email': 'isidrofe@ucm.es', 'phone': '34625598970'}], 'overallOfficials': [{'name': 'Isidro Fernández-López, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Complutense de Madrid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Isidro Fernández López', 'investigatorAffiliation': 'Universidad Complutense de Madrid'}}}}