Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT07296718
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2025-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Vs Multi-strain Probiotics for Preterm Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071074', 'term': 'Neonatal Sepsis'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-10', 'size': 130155, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-12-08T12:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Placebo-controlled randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Necrotizing enterocolitis (NEC)', 'timeFrame': 'From the day intervention started to day 28 of supplementation', 'description': "Bell's classification used for grading and diagnosis"}], 'secondaryOutcomes': [{'measure': 'Neonatal Sepsis', 'timeFrame': 'From the day intervention started to day 28 of supplementation', 'description': 'Clinical sepsis is defined as condition with at least two signs of systemic inflammatory response (e.g. temperature \\>38 C or \\<36.5 C, tachycardia \\> 200/min etc.), one laboratory sign (e.g. C-reactive protein \\>20mg/L) but no proof of causative agent in blood culture. Clinical sepsis with proof of blood culture positive for causative agent was defined as confirmed sepsis.'}, {'measure': 'Feeding Intolerance', 'timeFrame': 'From the day intervention started to day 28 of supplementation', 'description': 'A gastrointestinal tolerance score, based on gastric residual volume, emesis, abdominal distension, number of stools and nil per oral days was calculated to identify and score feeding intolerance. Each score as 1. A score of \\>2 was considered gastric intolerance.'}, {'measure': 'Weight', 'timeFrame': 'From the day intervention started to day 28 of supplementation', 'description': 'Weight measured in grams'}, {'measure': 'Body length', 'timeFrame': 'From the day intervention started to day 28 of supplementation', 'description': 'Measured in millimeters daily once'}, {'measure': 'Head Circumference', 'timeFrame': 'From the day study started to day 28 of supplementation', 'description': 'Measured in millimeters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Probiotics', 'Preterm neonates', 'Single vs Multiple strain'], 'conditions': ['Necrotizing Enterocolitis of Newborn', 'Sepsis Newborn', 'Growth', 'Feeding Intolerance']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized control clinical trial is to determine if probiotics can prevent mortality and morbidity in preterm neonates. It also evaluates effects of probiotics on feeding pattern and growth. It will also learn about the comparative effects of single vs multiple strain probiotics.\n\nIt aims to answer:\n\nDoes probiotics improve the health and growth outcomes in preterm neonates in our population? Does single vs multiple strain of probiotics have difference in effects?\n\nParticipants will:\n\nParticipants given either single strain or multiple strain probiotics for 28 days post birth.\n\nData about mortality, morbidity, feeding pattern and growth (weight, height, head circumference gain) recorded on daily basis.', 'detailedDescription': "This trial is single-centered, parallel, multi-arm, 1:1:1 randomized, blinded, placebo controlled clinical trial. It compares 3 groups; Group P1 (Placebo), Group P2-Single Strain probiotic (Lactobacillus rhamnosus GG) and Group P3- Multiple strains probiotic ( Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4) for preventing preterm neonatal morbidities, improving feeding tolerance and overall growth.\n\nPrimary objective: The primary objective of our trial will be to compare the incidence and severity of Necrotizing enterocolitis (NEC) from the time of trial participation till the end of trial treatment (28 days) according to Bell's grading criteria.\n\nSecondary objectives:\n\nAll these outcomes will be measured from the day intervention started to the end of supplementation (28 days)\n\n* To evaluate incidence of sepsis, intracerebral haemorrhage and periventricular leukomalacia, retinopathy of prematurity and bronchopulmonary dysplasia)\n* To estimate the time to full enteral feeding (i.e., ≥150 ml/kg/day) and feeding tolerance based on Davy's Neonatal Feeding Assessment Scale (NFAS).\n* To determine the effect of probiotics on growth (weight, height, and head circumference) of premature babies\n* To assess comparative efficacy of single strain vs combination probiotics for aforementioned objectives\n\nFramework/hypothesis: The experimental group P2 (Lactobacillus rhamnosus GG) and Group P3- ( Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4) are superior to control group (Placebo) as preventing NEC and other morbidities in preterm neonates, thus improving feeding tolerance and overall growth."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPreterm babies of gestational age \\<35+6days, birth weight \\<2500 grams, received and tolerated at-least one feed within 72 hours of birth and informed consent from parents or guardian.\n\nExclusion Criteria:\n\n* Neonates with major congenital malformations, gastrointestinal anomalies, early onset sepsis (C-reactive protein (CRP) \\>10 mg/L in the first 72 h of life) and renal insufficiency'}, 'identificationModule': {'nctId': 'NCT07296718', 'briefTitle': 'Single Vs Multi-strain Probiotics for Preterm Neonates', 'organization': {'class': 'OTHER', 'fullName': 'The Islamia University of Bahawalpur, Khawaja Fareed CampusDr'}, 'officialTitle': 'Evaluation of the Clinical and Growth-related Effects of Probiotics in Preterm Infants: A Randomized, Placebo Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'NEOPRO-SvsM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'P1', 'description': '1 ml of 10% dextrose water will be dispensed in 5cc syringe and administered orally or via feeding tube for 28 days.', 'interventionNames': ['Dietary Supplement: Dextrose 10%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'P2', 'description': 'Single strain probiotic- Lactobacillus rhamnosus GG. The single dose 1.5×109 CFU/day as 1 mL of the reconstituted solution will be given every day via the feeding tube or orally as applicable until reaching feeds of 50 mL/kg/day. It will be increased thereafter to 3×109 CFU/day once feeds exceed 50mL/kg/day.', 'interventionNames': ['Drug: Lactobacillus Rhamnosus GG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'P3', 'description': 'Multiple strain probiotic-Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4.\n\nThe single dose 1.5×109 CFU/day as 1 mL of the reconstituted solution will be given every day via the feeding tube or orally as applicable until reaching feeds of 50 mL/kg/day. It will be increased thereafter to 3×109 CFU/day once feeds exceed 50mL/kg/day.', 'interventionNames': ['Drug: Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4']}], 'interventions': [{'name': 'Dextrose 10%', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Placebo'], 'description': 'P1', 'armGroupLabels': ['P1']}, {'name': 'Lactobacillus Rhamnosus GG', 'type': 'DRUG', 'otherNames': ['Prepro GG'], 'description': 'Single Strain', 'armGroupLabels': ['P2']}, {'name': 'Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4', 'type': 'DRUG', 'otherNames': ['Amybact'], 'description': 'Multiple Strain', 'armGroupLabels': ['P3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62100', 'city': 'Bahawalpur', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Bahawal Victoria Hospital', 'geoPoint': {'lat': 29.99835, 'lon': 73.25272}}], 'overallOfficials': [{'name': 'Imran Masood, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Islamia University of Bahawalpur, Khawaja Fareed Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Madiha, MPhil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Co-investigator', 'investigatorFullName': 'Madiha, MPhil', 'investigatorAffiliation': 'The Islamia University of Bahawalpur, Khawaja Fareed CampusDr'}}}}