Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-02-25 @ 5:50 PM
Study NCT ID:
NCT07070856
Status:
COMPLETED
Last Update Posted:
2025-08-24
First Post:
2025-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Rice-Based F-75 in Severe Malnutrition & Persistent Diarrhea in Children (SAM-RICE Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067011', 'term': 'Severe Acute Malnutrition'}, {'id': 'D011502', 'term': 'Protein-Energy Malnutrition'}, {'id': 'D007787', 'term': 'Lactose Intolerance'}], 'ancestors': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D011488', 'term': 'Protein Deficiency'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002239', 'term': 'Carbohydrate Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012436', 'term': 'S-Adenosylmethionine'}], 'ancestors': [{'id': 'D008715', 'term': 'Methionine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2025-06-28', 'studyFirstSubmitQcDate': '2025-07-09', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'hydration status', 'timeFrame': 'day 1 to day 7 of treatment', 'description': 'IMNCI Protocol'}, {'measure': 'Re feeding syndrome', 'timeFrame': 'Day 1 to day 7 of treatment with therapeutic feed', 'description': 'monitoring of vitals,edema,heart failure,electrolytes imbalance,convulsions'}, {'measure': 'Electrolytes monitoring', 'timeFrame': 'Time Frame: Baseline and Day 4', 'description': '\\- Serum Sodium and potassium Unit of Measure: mmol/L'}], 'primaryOutcomes': [{'measure': 'stool frequency', 'timeFrame': 'day 1 to day 7 of starting therapeutic feed', 'description': 'episodes of loose stools per day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Severe Acute Malnutrition', 'Persistent Diarrhea', 'F-75 Formula', 'Rice-Based Diet', 'Nutritional Rehabilitation', 'Protein-Energy Malnutrition', 'Lactose intolerance'], 'conditions': ['Severe Acute Malnutrition', 'Persistent Diarrhea', 'Children']}, 'referencesModule': {'references': [{'pmid': '32590986', 'type': 'BACKGROUND', 'citation': 'Facioni MS, Raspini B, Pivari F, Dogliotti E, Cena H. Nutritional management of lactose intolerance: the importance of diet and food labelling. J Transl Med. 2020 Jun 26;18(1):260. doi: 10.1186/s12967-020-02429-2.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to find out if a rice-based version of the F-75 therapeutic food helps children with severe acute malnutrition (SAM) and persistent diarrhea recover better than the standard commercial F-75.\n\nThe main questions it aims to answer are:\n\n1. Does rice-based F-75 reduce the duration of diarrhea and improve nutritional recovery in children with SAM?\n2. Is rice-based F-75 as safe and well-tolerated as the standard WHO F-75?\n\nResearchers will compare two groups:\n\nOne group will receive the new rice-based F-75. The other group will receive the standard F-75.\n\nParticipants will:\n\n1. Be children aged 6 to 59 months admitted with SAM and persistent diarrhea\n2. Be randomly assigned to one of the two feeding groups\n3. Stay in a hospital ward for monitoring during the stabilization phase\n\nBe assessed daily for:\n\nStool frequency Weight changes Appetite Medical problems or side effects\n\nThis study will help determine whether the rice-based F-75 is a better option for malnourished children with diarrhea.', 'detailedDescription': 'Persistent diarrhea in children with severe acute malnutrition (SAM) poses a significant clinical challenge, particularly during the stabilization phase. Standard therapeutic protocols include the use of F-75-a milk-based formula designed to meet the reduced metabolic demands of severely malnourished children. However, lactose content in milk-based F-75 may exacerbate intestinal symptoms in children with secondary lactase deficiency, commonly observed in cases of persistent diarrhea.\n\nRice-based therapeutic formulations have emerged as promising alternatives, potentially offering superior gastrointestinal tolerance, improved nutrient absorption, and reduced osmolarity compared to conventional milk-based F-75. Rice is hypoallergenic, low in anti-nutritional factors, and contains resistant starches that may support gut integrity and microbial balance during intestinal recovery.\n\nIntroducing rice-based F-75 may address dietary intolerance in children with diarrhea-induced lactase deficiency, particularly in low-resource settings where commercial lactose-free preparations are unavailable or unaffordable. This trial seeks to assess whether therapeutic feeding with rice-based F-75 leads to faster stabilization without compromising metabolic safety or nutritional adequacy.Participants are randomized into intervention and control arms during hospitalization, receiving either rice-based or conventional F-75 during the stabilization phase. Transition to F-100 occurs per clinical criteria once acute symptoms resolve.\n\nClinical monitoring includes:\n\n* Gastrointestinal Tolerance: Stool frequency, consistency, abdominal distension, emesis, and need for additional rehydration.\n* Metabolic Safety: Serum sodium, potassium, bicarbonate, and creatinine levels evaluated at baseline and mid-stabilization.\n* Nutritional Stabilization: Daily weight, mid-upper arm circumference (MUAC), and feeding tolerance.\n* Adverse Events Surveillance: Identification of allergic responses, metabolic complications, or mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the children admitted to the hospital with complaints of persistent diarrhea\n* secondary lactose\n\nExclusion Criteria:\n\n* All the children with primary lactose intolerance\n* Those parents /guardians refused permission to participate in the study.\n* Critically ill child admitted to ICUs and emergency department.\n* Patients started therapeutic feeding prior to recruitment in study .'}, 'identificationModule': {'nctId': 'NCT07070856', 'acronym': 'SAM-RICE', 'briefTitle': 'Trial of Rice-Based F-75 in Severe Malnutrition & Persistent Diarrhea in Children (SAM-RICE Study)', 'organization': {'class': 'OTHER_GOV', 'fullName': "Children's Hospital and Institute of Child Health, Multan"}, 'officialTitle': 'Efficacy and Safety of Therapeutic Rice Based F75 In Severely Acute Malnourished Children With Persistent Diarrhea.;A Randomized Control Trial.', 'orgStudyIdInfo': {'id': 'U1111-1324-6540'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'WHO standard f75', 'description': 'standard ,prepared.powdered F75 by WHO', 'interventionNames': ['Dietary Supplement: WHO-recommended standard therapeutic milk used for stabilization phase in SAM)']}, {'type': 'EXPERIMENTAL', 'label': 'Rice Based F75', 'description': 'Rice based F75 BY WHO recipe for PERSISTENT Diarhea', 'interventionNames': ['Dietary Supplement: HO-recommended Rice based therapeutic milk used for stabilization phase in SAM)']}], 'interventions': [{'name': 'WHO-recommended standard therapeutic milk used for stabilization phase in SAM)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Stabalization phase feed'], 'description': 'F75 GIVEN INITIALLY 2HOURLY,130 ml per kg than 3 and 4hourly maximum takes 5 to 7 days.', 'armGroupLabels': ['WHO standard f75']}, {'name': 'HO-recommended Rice based therapeutic milk used for stabilization phase in SAM)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Rice based F75 GIVEN INITIALLY 2HOURLY,130 ml per kg than 3 and 4hourly maximum takes 5 to 7 days.', 'armGroupLabels': ['Rice Based F75']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60000', 'city': 'Multan Khurd', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Tehsil Head Quater Sujah Abad', 'geoPoint': {'lat': 33.03555, 'lon': 72.01752}}, {'zip': '60000', 'city': 'Multan Khurd', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'The Childrens Hospital and Instotute of Child Health Multan', 'geoPoint': {'lat': 33.03555, 'lon': 72.01752}}], 'overallOfficials': [{'name': 'Muhammad T Sultan, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bahauddin zakariya University,Multan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital and Institute of Child Health, Multan", 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pricipal Investigator', 'investigatorFullName': 'Dr. Saadia Khan', 'investigatorAffiliation': "Children's Hospital and Institute of Child Health, Multan"}}}}