The Tolerance of Organic Formula Milk and Its Fecal Microbiome Characteristic in Infants (TOFeM)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
South Sulawesi
-
Makassar、South Sulawesi、インドネシア、90245
- Hasanuddin University
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Participants with diarrhea defined by WHO definition of diarrhea
時間枠：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
時間枠：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
時間枠：12 Weeks
|
Evaluate any allergic reaction during organic formula milk consumption based on positive oral food challenge
|
12 Weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diversity of gut microbiota in operational taxonomic unit
時間枠：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
時間枠：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
時間枠：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
時間枠：12 weeks
|
Measurements of weight every 4 weeks
|
12 weeks
|
|
Body length in centimeters measured with Krisbow electronic baby scale 10110689
時間枠：12 weeks
|
Measurements of length every 4 weeks
|
12 weeks
|
|
Head circumference measured with Onemed medline tape measure
時間枠：12 weeks
|
Measurements of head circumference every 4 weeks
|
12 weeks
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Organic Formula Milkの臨床試験
-
Virginia Polytechnic Institute and State UniversityShady Grove Fertility Reproductive Science Center募集
-
University of PittsburghNational Institute of Nursing Research (NINR)完了
-
Endourage, LLC募集長い COVID | ロング Covid19 | ポスト急性COVID-19 | 長距離COVID | 長距離COVID-19 | ポスト急性COVID-19症候群アメリカ
-
Advanced Dermatology完了
-
University of Southern DenmarkAarhus University Hospital; Holbaek Sygehus; Kolding Sygehus完了アレルギー | 食事の変更 | 乳児、極低出生体重児 | メタボリックシンドローム、防御デンマーク