The Consumption Effect of Formula Milk With Triple Bifidobacteria Strains (Bifidobacterium Longum BB536, Bifidobacterium Breve M-16V, and Bifidobacterium Longum Subsp. Infantis M-63) on Fecal Quality and Metabolites in Healthy Children
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 103
- 试验地点
- 20
- 主要终点
- Fecal characteristics
研究概览
简要总结
The goal of this clinical trial is to compare healthy children between 1 to 3 years old. The main question it aims to answer is
- Is there an effect towards fecal quality after consuming milk formula supplemented with the triple Bifidobacteria strains (Bifidobacterium longum BB536, Bifidobacterium breve M-16V, and Bifidobacterium longum subsp. infantis M-63)?
- Is there an effect towards short-chain fatty acid composition after consuming milk formula supplemented with the triple Bifidobacteria strains (Bifidobacterium longum BB536, Bifidobacterium breve M-16V, and Bifidobacterium longum subsp. infantis M-63)?
- Is there an effect towards clinical profile after consuming milk formula supplemented with the triple Bifidobacteria strains (Bifidobacterium longum BB536, Bifidobacterium breve M-16V, and Bifidobacterium longum subsp. infantis M-63)?
The clinical trial period started off with all the participants consuming a milk formula three times a day, for 14 days as a baseline period. Afterwards, the participants were randomly assigned to one of two groups: probiotic and placebo. Following the baseline period, participants in the probiotic group consumed formulated milk supplemented with the triple Bifidobacteria strains, while the placebo group ingested the same formulated milk without adding triple Bifidobacteria strains for 90 days.
Researchers will compare the probiotic and placebo groups to see if there are any effects towards the fecal quality, short-chain fatty acid level and clinical profile after consuming the milk formula.
详细描述
This clinical trial is a study of 3 strains of Bifidobacterium was conducted in infants aged 1-3 years in Indonesia. The general objective of this study was to determine the benefits of combined supplementation of Bifidobacteria strains (B. longum BB536, B. breve M-16V, and B. longum subsp. infantis M-63) in healthy children aged 1-3 years. The study is conducted for 104 days with a baseline period of 14 days and continued with an intervention period of 90 days. Participants is divided into two groups, which are the intervention group and the placebo group. The study will be conducted using a double-blind randomized, placebo-controlled trial design. A total of 100 participants will be selected based on inclusion and exclusion criteria.
During the screening period (day 0), socialization of the research and signing of informed consent will be carried out for participants who are willing to participate. Participants were asked not to consume fermented milk products, probiotics and prebiotic fortified food/drinks while participating in research activities.
During the baseline period (Day 14), the participants were asked to consume control milk and, represented by their parents, were also asked to fill out research diaries in the form of diet records, records of probiotic products and prebiotic fortified food/drinks consumed, type and frequency of bowel movements, health complaints felt (discomfort, headaches, stomachaches, respiratory tract-related illnesses and fever), medication consumption records, days where the participants refused to eat. Participants were asked to collect research documents and collect stool samples on day 14 +/- 1.
During the intervention period, from day 15 to day 104, participants consumed 36 grams of the test product or placebo dissolved in 180 ml per serving with a consumption frequency of 3 times per day. Product consumption will be recorded in the product consumption logbook and on the subject's diary record form. Once every 2 weeks a health profile measurement (weight, height, arm circumference, head circumference, skinfold thickness) and sleep quality will be measured. Participants were asked to collect research documents and stool samples on day 104 +/- 1 with the same procedure as in the baseline period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 12 - 36 months
- •Normal nutritional status (z-score height-for-age or z-score weight-for-height: -2 SD < X < 2 SD)
- •Has no dairy allergies
- •Does not consume breastmilk anymore during the intervention period
- •Willing to participate through the whole research period
- •Obtain consent from parents or guardians by signing the informed consent form
排除标准
- •Has a history of lactose intolerance, congenital and chronic diseases including irritable bowel syndrome, etc.
- •Receive antibiotic or other probiotic supplementation during the 14 day of baseline period.
结局指标
主要结局
Fecal characteristics
时间窗: Before and after intervention period (day 13 and day 105)
Observed the shape, color and consistency of fecal samples that will be combined to be reported as fecal type according to the Bristol Stool Chart
Fecal pH
时间窗: Before and after intervention period (day 13 and day 105)
The pH of obtained fecal samples were measured using potential of hydrogen (pH) meter
Enterobactericaeae's cell count
时间窗: Before and after intervention period (day 13 and day 105)
The cell number is a total of Enterobacteriaceae's cells obtained from DNA extraction of stool samples counted using quantitative PCR (qPCR). Cell count will be expressed in colony forming unit per gram (CFU/g)
Short chain fatty acids analysis
时间窗: Before and after intervention period (day 13 and day 105)
The analysis includes the measurement of acetate, propionate, and butyrate. The analysis uses gas chromatography method.
Bacterial colony characteristics
时间窗: Before and after intervention period (day 13 and day 105)
From the fecal samples obtained, direct plating using the selective media for Bifidobacterium (Bifidobacterium Selective Medium or BSM) and Enterobacteriaceae (MacConkey Agar) is conducted. Colony bacterial characterization is based on the cell morphology and Gram strain characteristics under the microscope.
Bifidobacterium's cell count
时间窗: Before and after intervention period (day 13 and day 105)
The cell number is a total of Bifidobacteria cells obtained from DNA extraction of stool samples counted using quantitative PCR (qPCR). Cell count will be expressed in colony forming unit per gram (CFU/g).
Biomarker of immune systems
时间窗: Before and after intervention period (day 13 and day 105)
The analysis on immune systems' biomarker uses the fecal water obtained from diluting the fecal samples into phosphate buffer. The fecal water is then added with protease inhibitor to keep fecal samples stable during the analysis. The immune system analyzed are interleukin 6 (IL6), interleukin 8 (IL8), interleukin 10 (IL10) and secretory immunoglobulin A (SIgA). All immune systems are read using the enzyme-linked Immunosorbent Assay (ELISA) Reader BioRad iMark.
次要结局
- Height(Once every two weeks for 105 days)
- Dietary pattern records(Four days every two weeks, consists of two weekdays and two weekend days during the research period)
- Health profile record(Before and after intervention period (day 13 and day 105))
- Weight(Once every two weeks for 105 days)
- Defecation frequency records(Everyday during the research period (104 days))
- Health complaint and medical records(Everyday during the research period (104 days))
- Gastrointestinal disorder record(Before and after intervention period (day 13 and day 105))
- Sleep quality(Before and after intervention period (day 13 and day 105))
- Behaviour assesment(Before and after intervention period (day 13 and day 105))
- Development screening(Before and after intervention period (day 13 and day 105))
- Arm circumference(Once every two weeks for 105 days)
- Triceps thickness(Once every two weeks for 105 days)
- Psychosocial problems(Before and after intervention period (day 13 and day 105))
- Body Mass Index (BMI)(Once every two weeks for 105 days)
- Subcutaneous fat thickness(Once every two weeks for 105 days)
- Head circumference(Once every two weeks for 105 days)
- Medical check up(Once every two weeks for 105 days)
研究者
Endang Sutriswati Rahayu
Principal Investigator
Gadjah Mada University