Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-28 @ 5:19 AM
Study NCT ID:
NCT06926166
Status:
RECRUITING
Last Update Posted:
2025-04-13
First Post:
2025-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Genes and Microbiota in Early Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'During pregnancy: maternal blood, urine, and stool. At delivery: cord, cord blood, and placenta. During infancy: dry blood spots, stool, and blood. During childhood: blood, buccal swab, and stool.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2038-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2025-03-26', 'studyFirstSubmitQcDate': '2025-04-07', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2038-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numbers of participants with Childhood diseases. Including:', 'timeFrame': '42 days, 6 months, 1, 3, 6, 8-9, 14, and18 years of age', 'description': 'Obesity，asthma，allergic diseases，Delayed neural development，type 1 diabetes，maturity-onset diabetes of the young（MODY), hypertension'}, {'measure': 'Numbers of participants with maternal diseases. Including:', 'timeFrame': 'during pregnancy, 42 days, 6 months, 1, 3, 6, 8-9, 14, and18 years after delivery', 'description': 'Obesity，asthma，allergic diseases，type 1 diabetes，type 2 diabetes, hypertension , cardiovascular diseases，and obstetric complications，including gestational diabetes，pregnancy induced hypertension, ect.'}], 'secondaryOutcomes': [{'measure': 'Neurodevelopment during early childhood', 'timeFrame': 'at age of 3 years', 'description': 'Including adaptive, gross motor, fine motor,language,and social function; assessed using Gesell Developmental Schedules'}, {'measure': 'Neurodevelopment during early childhood', 'timeFrame': 'at age of 3 years', 'description': 'Including adaptive, gross motor, fine motor,language,and social function; assessed using Ages and Stages Questionnaire'}, {'measure': 'Neurodevelopment during preschool age', 'timeFrame': 'at age of 6 years', 'description': "Including solving skills, pattern perception, and logical thinking；assessed using Raven's Standard Progressive Matrices"}, {'measure': 'Neurodevelopment during preschool age', 'timeFrame': 'at age of 6 years', 'description': 'Including solving skills, pattern perception, and logical thinking；assessed using Peabody Picture Vocabulary Test'}, {'measure': 'Neurodevelopment during preadolescence', 'timeFrame': 'at age of 8-9 years', 'description': "Including higher-level cognitive processes such as attention, perseverance, WM, abstract thinking, CF, and set shifting;assessed using Raven's Standard Progressive Matrices"}, {'measure': 'Neurodevelopment during preadolescence', 'timeFrame': 'at age of 8-9 years', 'description': 'Including higher-level cognitive processes such as attention, perseverance, WM, abstract thinking, CF, and set shifting;assessed using Wsiconsin card sorting test'}, {'measure': 'maternal and childhood abnormal glucose metabolism after delivery', 'timeFrame': '3, 6 and 9 years after delivery', 'description': 'blood glucose level：glycosylated hemoglobin，fasting blood glucose, 1-hour glucose, 2-hour glucose, ect.'}, {'measure': 'maternal and childhood abnormal lipid metabolism after delivery', 'timeFrame': '3, 6 and 9 years after delivery', 'description': 'Lipid level : total cholesterol, triglycerides, LDL, HDL, etc.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Host and Microbiome', 'Pregnancy Outcomes', 'Pregnancy Complications', 'Neurodevelopmental Disorders', 'Immune Development', 'Childhood Obesity', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '28321694', 'type': 'BACKGROUND', 'citation': 'Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-0239-x. Epub 2017 Mar 20.'}, {'pmid': '28873967', 'type': 'BACKGROUND', 'citation': 'Kuang YS, Lu JH, Li SH, Li JH, Yuan MY, He JR, Chen NN, Xiao WQ, Shen SY, Qiu L, Wu YF, Hu CY, Wu YY, Li WD, Chen QZ, Deng HW, Papasian CJ, Xia HM, Qiu X. Connections between the human gut microbiome and gestational diabetes mellitus. Gigascience. 2017 Aug 1;6(8):1-12. doi: 10.1093/gigascience/gix058.'}, {'pmid': '37929652', 'type': 'BACKGROUND', 'citation': 'Gao C, Shao DT, Wang CR, Kuang YS, Lu JH, Zeng DY, He JR, Qiu X. Long-term effect of caesarean section on the gut microbial taxonomical profile and metabolic function of children at pre-school age. Clin Transl Med. 2023 Nov;13(11):e1470. doi: 10.1002/ctm2.1470. No abstract available.'}, {'pmid': '27827448', 'type': 'BACKGROUND', 'citation': 'Kuang YS, Li SH, Guo Y, Lu JH, He JR, Luo BJ, Jiang FJ, Shen H, Papasian CJ, Pang H, Xia HM, Deng HW, Qiu X. Composition of gut microbiota in infants in China and global comparison. Sci Rep. 2016 Nov 9;6:36666. doi: 10.1038/srep36666.'}, {'pmid': '27226242', 'type': 'BACKGROUND', 'citation': 'Guo Y, Li SH, Kuang YS, He JR, Lu JH, Luo BJ, Jiang FJ, Liu YZ, Papasian CJ, Xia HM, Deng HW, Qiu X. Effect of short-term room temperature storage on the microbial community in infant fecal samples. Sci Rep. 2016 May 26;6:26648. doi: 10.1038/srep26648.'}]}, 'descriptionModule': {'briefSummary': 'The long-term goal of the Human Genes and Microbiota in Early Life (HuGME) is to explore the short- and long-term effects of maternal microbiota during pregnancy and the microbiota colonization of their offspring early in life and their interaction with the host on maternal-offspring health consequences in later life in the born in Guangzhou cohort study in China. Identification of the effect of microbiota in early life, as well as environmental factors and microbe-host interaction, will lead to a better understanding of disease pathogenesis and provide a foundation for targeted mechanistic investigation into the consequences of microbial-host crosstalk for long-term health. It also can result in new strategies to predict and prevent diseases in later life.', 'detailedDescription': 'Prenatal and early postnatal life represent critical windows for growth and cognitive and immune system development. In addition to genetics and host biology, the environment plays a critical role in the health of a child. One key player in this process is the maternal and infant gut microbiomes. The establishment and progression of the intestinal microbiota from birth to childhood are dependent on a range of factors, including maternal microbiota, diet, environment, and medical exposures. The host-microbial crosstalk during this time is thought to be involved in the pathobiology of later-life diseases, such as allergic disease, obesity, and neurodevelopmental delay. Although the microbiome and its importance for health have been extensively studied, it remains unclear how maternal microbiota-fetal interaction, the establishment, and progression of microbiota in infant adaptation to postnatal environmental exposures, and microbial-host crosstalk affect the health of the children in later life.\n\nHypotheses:\n\n1. Maternal microbiota-fetal interaction has an essential effect on fetal immune system development and adverse pregnancy outcomes.\n2. Host genes can shape infant gut microbial assembly and metabolism.\n3. Early-life interactions between host genes and microbiota have an impact on immune system development and atopic disease in later life.\n4. Co-metabolism of the gut microbiome and metabolites in the host affects childhood obesity\n5. Early-life interactions between the host and microbiota have an impact on the neurodevelopment of the children.\n6. Maternal microbiota influence the metabolism of the mother during pregnancy and postpartum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women attending their first routine antenatal examinations (usually around week 16) and their partners and offsrping', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPregnant women with \\< 20 weeks of gestation Pregnant women intended to eventually deliver in Guangzhou Women and Children's medical center Permanent residengts of families intended to remain in Guangzhou with their child for ≥3 years\n\nExclusion Criteria:\n\nRefuses to have blood and stool samples stored at Born in Guangzhou cohort study Biobank."}, 'identificationModule': {'nctId': 'NCT06926166', 'acronym': 'HuGME', 'briefTitle': 'Human Genes and Microbiota in Early Life', 'organization': {'class': 'OTHER', 'fullName': "Guangzhou Women and Children's Medical Center"}, 'officialTitle': 'Human Genes and Microbiota in Early Life (HuGME)', 'orgStudyIdInfo': {'id': '201807010086'}, 'secondaryIdInfos': [{'id': '82003471', 'type': 'OTHER_GRANT', 'domain': 'National natural science foundation of China'}, {'id': '2021A1515110194', 'type': 'OTHER_GRANT', 'domain': 'GuangDong Basic and Applied Basic Research Foundation'}, {'id': 'SL2024A04J0217', 'type': 'OTHER_GRANT', 'domain': 'Guangzhou Science and Technology Project'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'No treatment', 'description': 'No treatment', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['No treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiu Qiu, MD,PhD', 'role': 'CONTACT', 'email': 'xiu.qiu@bigcs.org', 'phone': '86-020-38367160'}, {'name': 'Jian-Rong He, MD, PhD', 'role': 'CONTACT', 'email': 'jianrong.he@bigcs.org', 'phone': '86-020-38367160'}], 'facility': "Guangzhou Women and Children's Medical Center, China", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xiu Qiu,, PhD', 'role': 'CONTACT', 'email': 'qxiu0161@163.com', 'phone': '0086 20 38367160'}, {'name': 'Jianrong He, PhD', 'role': 'CONTACT', 'email': 'jianrong.he@bigcs.org', 'phone': '0086 20 38367159'}], 'overallOfficials': [{'name': 'Xiu Qiu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Study Principal Investigator Guangzhou Women and Children's Medical Center, China"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangzhou Women and Children's Medical Center", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The division of the born in Guangzhou cohort study', 'investigatorFullName': 'Xiu Qiu', 'investigatorAffiliation': "Guangzhou Women and Children's Medical Center"}}}}