Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-01-27 @ 8:01 AM
Study NCT ID:
NCT01721850
Status:
TERMINATED
Last Update Posted:
2022-01-20
First Post:
2012-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003085', 'term': 'Colic'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, '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': 169}}, 'statusModule': {'whyStopped': 'Trial insurance could not be prolonged any more and expired', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-04', 'studyFirstSubmitDate': '2012-10-30', 'studyFirstSubmitQcDate': '2012-11-02', 'lastUpdatePostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'daily total crying time', 'timeFrame': '28 days', 'description': 'evaluation of the difference in the average reduction of daily crying time after 28 days of intervention between treatment and control group'}], 'secondaryOutcomes': [{'measure': 'growth parameters', 'timeFrame': '90 days', 'description': 'determination of body weight, length, head circumference'}, {'measure': 'tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects', 'timeFrame': '28 days', 'description': 'stool characteristics: frequency, consistency and color; gastrointestinal disorders: regurgitation, obstipation; side effects: vomiting, diarrhea, skin reactions'}, {'measure': 'formula intake', 'timeFrame': '28 days', 'description': 'evaluation of average daily drinking amount and formula acceptance'}, {'measure': 'intestinal microbiota', 'timeFrame': '0-28 days', 'description': 'evaluation of changes in the composition of the intestinal microbiota (Lactobacilli, Bifidobacteria, Coliforms) after intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['infant nutrition, infantile colic'], 'conditions': ['Infantile Colic']}, 'descriptionModule': {'briefSummary': 'The study is conducted to examine the safety and efficacy of a new infant formula and its effects on the gastrointestinal tolerance in infants suffering from colic.\n\nPrimary hypothesis to be tested is: an infant formula with optimized composition improves colicky symptoms compared to a standard formula.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Days', 'minimumAge': '15 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy term infants\n* Subjects appropriate for gestational age between 35 and 41 weeks\n* Subjects between 15-60 days old\n* Subjects with birth weight between 2500 and 4200 g and regular weight gain (≥150g / week)\n* Diagnosis of infantile colic according to modified Wessel criteria (Crying episodes lasting 3 or more hours/day and occurring at least 3 days/week for at least 1 week)\n* Subjects exclusively bottle-fed at study entrance\n* Day care of the child only by mother/father\n* Provide written informed consent in accordance with legal requirement\n\nExclusion Criteria:\n\n* Neonatal problems (respiratory distress, asphyxia, Hypoglycaemia, sepsis, NEC)\n* Clinical evidence of chronic illness or gastrointestinal disorders (GER, gastroenteritis)\n* Assumption of any kind of medication (except vitamin D, vitamin K and fluoride prophylaxis) during the week before the beginning of the study and during the study period\n* Subjects receiving formula for special medical purposes\n* Exclusively breast-fed infants\n* Feeding of supplemental Pro- and/or Prebiotics two weeks prior to inclusion\n* Allergic diseases (manifest atopic dermatitis, cow's milk allergy)\n* Participation in any other clinical intervention"}, 'identificationModule': {'nctId': 'NCT01721850', 'acronym': 'Coco', 'briefTitle': 'Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic', 'organization': {'class': 'INDUSTRY', 'fullName': 'HiPP GmbH & Co. Vertrieb KG'}, 'officialTitle': 'Evaluation of the Safety and Efficacy of New Infant Formula and Its Effects on the Gastrointestinal Tolerance (Crying Time) in Infantile Colic: a Double-blind, Randomized, Controlled Intervention Study', 'orgStudyIdInfo': {'id': 'HiPP-505092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control formula', 'description': 'infants are fed a commercial stage 1 infant formula during the first 4 months of life, according to protocol', 'interventionNames': ['Other: control formula']}, {'type': 'EXPERIMENTAL', 'label': 'intervention formula 1 group', 'description': 'infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol', 'interventionNames': ['Other: intervention formula 1']}, {'type': 'EXPERIMENTAL', 'label': 'intervention formula 2 group', 'description': 'infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol', 'interventionNames': ['Other: intervention formula 2']}], 'interventions': [{'name': 'control formula', 'type': 'OTHER', 'description': 'commercial stage 1 infant formula', 'armGroupLabels': ['control formula']}, {'name': 'intervention formula 1', 'type': 'OTHER', 'description': 'infant formula with hydrolyzed protein (type I) and pre- and probiotics', 'armGroupLabels': ['intervention formula 1 group']}, {'name': 'intervention formula 2', 'type': 'OTHER', 'description': 'infant formula with hydrolyzed protein (type II) and pre- and probiotics', 'armGroupLabels': ['intervention formula 2 group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40223', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Pediatric Office', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '77694', 'city': 'Kehl', 'country': 'Germany', 'facility': 'Pediatric Office', 'geoPoint': {'lat': 48.57297, 'lon': 7.81523}}, {'zip': '45475', 'city': 'Mülheim', 'country': 'Germany', 'facility': 'Pediatric Office', 'geoPoint': {'lat': 51.43218, 'lon': 6.87967}}, {'zip': '10141', 'city': 'Alba', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Pediatric office', 'geoPoint': {'lat': 44.6999, 'lon': 8.0347}}, {'zip': '10053', 'city': 'Borgone', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Pediatric office', 'geoPoint': {'lat': 45.97263, 'lon': 8.07941}}, {'zip': '10022', 'city': 'Carmagnola', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Pediatric office', 'geoPoint': {'lat': 44.84963, 'lon': 7.72032}}, {'zip': '10055', 'city': 'Condove', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Pediatric Office', 'geoPoint': {'lat': 45.11591, 'lon': 7.30859}}, {'zip': '10090', 'city': 'Mondovì', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Pediatric office', 'geoPoint': {'lat': 44.39603, 'lon': 7.81764}}, {'zip': '10099', 'city': 'San Mauro Torinese', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Pediatric office', 'geoPoint': {'lat': 45.10359, 'lon': 7.76803}}, {'zip': '10078', 'city': 'Turin', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Pediatric office', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '10124', 'city': 'Turin', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Pediatric office', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '10126', 'city': 'Turin', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Pediatric office', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '10132', 'city': 'Turin', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Pediatric Office', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '10137', 'city': 'Turin', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Pediatric Office', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '10148', 'city': 'Turin', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Pediatric office', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '10149', 'city': 'Turin', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Pediatric office', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '10088', 'city': 'Volpiano', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Pediatric Office', 'geoPoint': {'lat': 45.1994, 'lon': 7.77546}}, {'zip': '10040', 'city': 'Volvera', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Pediatric Office', 'geoPoint': {'lat': 44.95484, 'lon': 7.51142}}], 'overallOfficials': [{'name': 'Francesco Savino, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ospedale Infantile Regina Margherita, Dipartimento di Scienze Pediatriche e dell'Adolescenza."}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HiPP GmbH & Co. Vertrieb KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}