Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-25 @ 4:07 PM
Study NCT ID:
NCT04620057
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2020-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Butyrate Against Pediatric Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002087', 'term': 'Butyrates'}], 'ancestors': [{'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, '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': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-31', 'studyFirstSubmitDate': '2020-10-26', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI z-score change', 'timeFrame': 'after 6 months from the start of intervention', 'description': 'BMI z-score change at least of ≥ 0.25'}], 'secondaryOutcomes': [{'measure': 'waist circumference', 'timeFrame': 'after 6 months from the start of intervention', 'description': 'mean waist circumference change'}, {'measure': 'HOMA index change', 'timeFrame': 'after 6 months from the start of intervention', 'description': 'mean of HOMA index change'}, {'measure': 'fasting glucose change', 'timeFrame': 'after 6 months from the start of intervention', 'description': 'mean of fasting glucose change'}, {'measure': 'fasting insulin change', 'timeFrame': 'after 6 months from the start of intervention', 'description': 'mean of fasting insulin change'}, {'measure': 'total cholesterol change', 'timeFrame': 'after 6 months from the start of intervention', 'description': 'mean of total cholesterol change'}, {'measure': 'Low density Lipoprotein cholesterol change', 'timeFrame': 'after 6 months from the start of intervention', 'description': 'mean of Low density Lipoprotein cholesterol change'}, {'measure': 'High density Lipoprotein cholesterol change', 'timeFrame': 'after 6 months from the start of intervention', 'description': 'mean of high density Lipoprotein cholesterol change'}, {'measure': 'plasma triglycerides change', 'timeFrame': 'after 6 months from the start of intervention', 'description': 'mean of plasma triglycerides change'}, {'measure': 'micro RNA 221- expression', 'timeFrame': 'after 6 months from the start of intervention', 'description': 'mean of mir221- expression'}, {'measure': 'serum ghrelin', 'timeFrame': 'after 6 months from the start of intervention', 'description': 'mean of serum ghrelin'}, {'measure': 'serum Interleukin-6', 'timeFrame': 'after 6 months from the start of intervention', 'description': 'mean of Interleukin-6'}, {'measure': 'composition of the intestinal microbiota (metagenomics characteristics)', 'timeFrame': 'after 6 months from the start of intervention', 'description': 'evaluation of gut microbiota structure by shotgun analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Childhood']}, 'referencesModule': {'references': [{'pmid': '36469320', 'type': 'DERIVED', 'citation': 'Coppola S, Nocerino R, Paparo L, Bedogni G, Calignano A, Di Scala C, de Giovanni di Santa Severina AF, De Filippis F, Ercolini D, Berni Canani R. Therapeutic Effects of Butyrate on Pediatric Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2244912. doi: 10.1001/jamanetworkopen.2022.44912.'}]}, 'descriptionModule': {'briefSummary': 'Worldwide obesity is a public health concern that is defined by the World Health Organization as abnormal or excessive fat accumulation that may impair health. The main drivers of obesity pathogenesis seem to be a long-term of energy discrepancy between too many calories consumed and an increase of sedentary behavior. A growing body of evidence suggests that the set of microbes that live within the digestive tract, making up the gut microbiota (GM), play a metabolic role in energy regulation and substrate metabolism. Various factors can impact GM, one of these are dietary compounds that deeply affect the growth and metabolism of gut bacteria, since fermentation of nutrients is one core function of the intestinal microbes. Among fermentation products an array of small organic metabolites are short-chain fatty acids (SCFAs) acetate, propionate and butyrate. Among SCFAs, the C-4 fatty acid butyrate, the main fuel for the colonocytes, might have a potential in alleviating obesity and related metabolic complications. Butyrate could act as a regulator of body weight: a reasonable speculation is that butyrate acts on components of the energy balance, promoting energy expenditure and/or reducing energy intake. Preclinical studies have shown that butyrate supplementation prevent high-fat diet-induced obesity and it is able to treat obesity. With the sharp increase of obesity prevalence seen in the pediatric population, novel insights are necessary to counteract this epidemic disease, the outcome of the study is to see whether oral butyrate supplementation could exert similar effect in obese children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children/adolescents with diagnosis of obesity (BMI \\>95° percentile for age and sex) observed at Pediatric Section of Department of Translational Medical Sciences (University of Naples Federico II)\n\nExclusion Criteria\n\n* Age at enrollment \\<5 or \\>17 years\n* BMI \\<95° percentile for age and sex\n* Patients under pharmacological treatment for obesity (metformin)\n* Patients assuming vitamin E,\n* Patients assuming pre-, pro- or synbiotics\n* Simultaneous presence of other chronic diseases unrelated to obesity:\n\n * cancer,\n * immunodeficiency,\n * cystic fibrosis,\n * allergies,\n * celiac disease,\n * autoimmune diseases,\n * neuropsychiatric disorders,\n * type 1 diabetes,\n * inflammatory bowel diseases,\n * malformations of urinary or gastrointestinal or respiratory tract,\n * chronic lung diseases, genetic and metabolic diseases,\n * chronic hematological diseases.\n* History of surgery for the treatment of obesity\n* Any medical condition that may interfere with participation in this study\n* Participation in other clinical trials still in progress'}, 'identificationModule': {'nctId': 'NCT04620057', 'acronym': 'BAPO', 'briefTitle': 'Effects of Butyrate Against Pediatric Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Effects of Oral Supplementation of Butyrate in Children With Obesity', 'orgStudyIdInfo': {'id': '29ES20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Butyrate + standard care for pediatric obesity', 'description': 'standard care for pediatric obesity + sodium butyrate (20 mg/kg body weight/day)', 'interventionNames': ['Dietary Supplement: butyrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo + standard care for pediatric obesity', 'description': 'standard care for pediatric obesity + placebo (cornstarch)', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'butyrate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'sodium butyrate (20 mg/kg body weight/day)', 'armGroupLabels': ['Butyrate + standard care for pediatric obesity']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'cornstarch', 'armGroupLabels': ['placebo + standard care for pediatric obesity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'University of Naples Federico II', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of the Pediatric Allergy Program at the Department of Translational Medical Science Chief of the ImmunoNutritionLab at CEINGE - Advanced Biotechnologies', 'investigatorFullName': 'Roberto Berni Canani, MD, PhD', 'investigatorAffiliation': 'Federico II University'}}}}