The Tolerance of Organic Formula Milk and Its Fecal Microbiome Characteristic in Infants (TOFeM)
연구 개요
상세 설명
All the guardians or parents of the participants in this study will be interviewed in order to record the dietary and sign for inform consent. Parents will be given a journal to record the participant's diet, any sign of colic on subjects, quality of sleep, and wellbeing. All the participants will be fed organic formula milk as a part of their dietary for 12 weeks. Before feeding the formula, the nutritional status will be measured and the participant's fecal will be collected for microbiome and short chain fatty acid (SCFA) examination. Every month the parents will be called in order to assess for child's sickness, allergy, body weight, length, head circumference, and to review their journal.
A visit follow up will be done before and after the study, the tolerance, nutritional status (including body mass index) and fecal collection for all subjects will be performed. The investigators will also collect the allergy related data. Each fecal examination will follow a strict cold chain procedure, each sample will be collected directly, bottled, and frozen to minimize error. The frozen samples will be transported in insulated bags with frozen ice blocks before being transferred to -80°C for storage.
A statistical analysis will be performed using r program and STATA 13.0. The Normality of data distribution will be tested using the Shapiro-Wilk test. To evaluate potential associations between factors in relation to fecal microbiome or SCFAs, Spearman's rank correlations will be calculated. A p-value <0.05 will be considered significant.
The model will be adjusted for potential confounders. Estimated associations will be described as odds ratios (ORs) with 95% confidence intervals (CIs). The non-parametric Wilcoxon test for paired samples will be used to compare different laboratory parameters at different times of collecting samples. The Mann-Whitney U test for unpaired samples will be applied to compare different categorical parameter between infants before and after treatment. Multivariable linear regressions will be done to find out the association of different parameters change before and after treatment.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
South Sulawesi
-
Makassar, South Sulawesi, 인도네시아, 90245
- Hasanuddin University
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy infants 6-7 months of age.
- Gestational age 38-42 weeks
- Birth weight >2700 and <4200 gram
- Not suffering from a major congenital anomaly, severely stunted at birth, not having a thyroid problem, not suffered from prominent gastrointestinal diseases, severe diseases at the time of inclusion (severe pneumonia, severe dehydration, etc)
- Parents want to follow the study by signing the informed consent
Exclusion Criteria:
- Subjects are in the severe disease condition at the time of recruitment
- Severe acute malnutrition
- Have conditions that will influence the nutritional status such as moderate to severe dehydration, organomegaly, edema.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Treatment group
Group of infants aged 6-7 months that given organic formula milk three times a day for three months.
Each serving contains 7 spoons (1 spoon contain 4,6 grams) of milk powder and 210 ml of water.
|
Organic formula milk is given to the infants three times a day for three months.
Each serving contains 7 spoons (1 spoon contain 4,6 grams) of milk powder and 210 ml of water.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Participants with diarrhea defined by WHO definition of diarrhea
기간: 12 weeks
|
Evaluate the acceptability of organic formula milk on infants by observing the stool consistency and frequency of passing stool
|
12 weeks
|
|
Participants with atopic dermatitis in Hanifin-Rajka criteria
기간: 12 Weeks
|
Evaluate any atopic dermatitis manifestation arise during organic formula milk consumption based on Hanifin Rajka Criteria
|
12 Weeks
|
|
Participants with food allergy measured by positive Oral Food Challenge
기간: 12 Weeks
|
Evaluate any allergic reaction during organic formula milk consumption based on positive oral food challenge
|
12 Weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Diversity of gut microbiota in operational taxonomic unit
기간: 12 weeks
|
Fecal samples obtained and fresh frozen by liquid nitrogen for 16S rRNA analysis Genomic DNA was extracted from fecal samples and purified using Genomic DNA from stool samples (Macherey-Nagel GmbH & Co. KG, Germany).
Each DNA specimen from feces was amplified using the Ion 16S Metagenomics Kit (Thermo Fisher Scientific, Bremen, Germany).
The amplicons were purified and prepared for the sequencing library by using the Ion Plus Fragment Library Kit (Thermo Fisher Scientific) and the Ion Personal Genome Machine (PGM) Hi-Q sequencing kit following the protocol of the kit.
The sequencing runs were performed on the Ion PGM platform (Thermo).
|
12 weeks
|
|
Abundance of gut microbiota in operational taxonomic unit
기간: 12 weeks
|
Fecal samples obtained and fresh frozen by liquid nitrogen for 16S rRNA analysis Genomic DNA was extracted from fecal samples and purified using Genomic DNA from stool samples (Macherey-Nagel GmbH & Co. KG, Germany).
Each DNA specimen from feces was amplified using the Ion 16S Metagenomics Kit (Thermo Fisher Scientific, Bremen, Germany).
The amplicons were purified and prepared for the sequencing library by using the Ion Plus Fragment Library Kit (Thermo Fisher Scientific) and the Ion Personal Genome Machine (PGM) Hi-Q sequencing kit following the protocol of the kit.
The sequencing runs were performed on the Ion PGM platform (Thermo).
|
12 weeks
|
|
Concentration of gut short chain fatty acids in mMol
기간: 12 weeks
|
Faecal samples obtained.
Reagen used is N-tert-butyldimethylsilyl-N-trifluoroace- tamide (MTBSTFA) (Sigma-Aldrich, St. Louis, MO, USA) and analysis was performed using gas chromatogra- phy-tandem mass spectrometry (GC/MS/MS) platforms on a Shimadzu GCMS-TQ8030 triple quadrupole mass spectrometer (Shimadzu, Kyoto, Japan) with a capillary column (BPX5) (SGE Analytical Science Pty. Ltd., Melbourne, Australia).
|
12 weeks
|
|
Body weight in kilograms measured with Krisbow electronic baby scale 10110689
기간: 12 weeks
|
Measurements of weight every 4 weeks
|
12 weeks
|
|
Body length in centimeters measured with Krisbow electronic baby scale 10110689
기간: 12 weeks
|
Measurements of length every 4 weeks
|
12 weeks
|
|
Head circumference measured with Onemed medline tape measure
기간: 12 weeks
|
Measurements of head circumference every 4 weeks
|
12 weeks
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Ohno H. Gut microbial short-chain fatty acids in host defense and immune regulation. Inflammation and regeneration. 2015;35:114-121
- Inoue Y, Shimojo N. Microbiome/microbiota and allergies. Semin Immunopathol. 2015 Jan;37(1):57-64. doi: 10.1007/s00281-014-0453-5. Epub 2014 Oct 18.
- Sakurai K, Miyaso H, Eguchi A, Matsuno Y, Yamamoto M, Todaka E, Fukuoka H, Hata A, Mori C; Chiba study of Mother and Children's Health Group. Chiba study of Mother and Children's Health (C-MACH): cohort study with omics analyses. BMJ Open. 2016 Jan 29;6(1):e010531. doi: 10.1136/bmjopen-2015-010531.
- Simonyte Sjodin K, Vidman L, Ryden P, West CE. Emerging evidence of the role of gut microbiota in the development of allergic diseases. Curr Opin Allergy Clin Immunol. 2016 Aug;16(4):390-5. doi: 10.1097/ACI.0000000000000277.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Organic Formula Milk에 대한 임상 시험
-
Virginia Polytechnic Institute and State UniversityShady Grove Fertility Reproductive Science Center모병
-
Endourage, LLC완전한
-
University of PittsburghNational Institute of Nursing Research (NINR)완전한
-
Endourage, LLC모병긴 COVID | 긴 Covid19 | 포스트 급성 COVID-19 | 장거리 COVID | 장거리 COVID-19 | COVID-19 후 증후군미국