Gastrointestinal Tract Flora CompositionNCT02317406
Effect of Probiotics on the Digestibility and Immunity in Infants
A study testing Biostime probiotics sachet children's formula in people with Gastrointestinal Tract Flora Composition, run by Biostime Institute of Nutrition and Care at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effect of the probiotic product on the GI tract flora composition. Read more about this study
- Who is it for?
- Ages 4 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Tract Flora Composition
- What is being tested?
- Biostime probiotics sachet children's formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants;
- Single birth;
- Gestational age ≥ 37 weeks (=non-preterm infant, WHO);
- Birth weight: > 2500g
- Appropriate weight between P20-P80 in accordance with the weight percentile standards of the children ages 0 to 6 years in Shanghai urban areas at inclusion visit ;
- Aged > 4 months and < 6 months;
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- Infants being exclusively formula-fed(no breast milk meal) at inclusion visit;
- No suffering of gastrointestinal diseases within 1 month (CCDC recommendations);
- Parents agreeing to use one of the recommended infant formulas (no probiotic, if with prebiotics, exclude it when there is GOS over 2g/100g or FOS inside);
- Consent form signed by at least one of the parents or by the legal tutor properly informed of the study;
- Parents able to understand the protocol requirements and to fill out the infants' diary.
Who cannot join
- Congenital illness or malformation;
- Significant pre-natal and/or post-natal disease;
- Mothers with metabolic or chronic diseases;
- Infants with allergic constitution and sensitive to the probiotics (CCDC recommendations);
- Infants with serious diseases, such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system diseases and internal secretion diseases, and those with mental disorder (CCDC recommendations);
- Infants administering other drugs during the administering of the study products, thus impossible to judge the efficacy or influencing the judgment of results (CCDC recommendations);
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- Infants known to have current or previous illnesses/conditions or intervention which could interfere with the study (impacting tolerance and/or growth), such as gastrointestinal malformations, chronic diarrhoea, malabsorptive syndrome, malnutrition, congenital immunodeficiency, or major surgery, as per investigator's clinical judgment;
- Infant under oral antibiotic treatment at V1 visit and within the 4 weeks before V1
- Infants who used any medication or nutritional supplements (including probiotics, prebiotics etc, except for infant formula) in the 4 weeks preceding study start;
- Infants who have ever consumed the test product;
- Infants who have medical conditions for which a special diet other than standard (non hydrolyzed) cow's milk-based infant formula is required (such as cow's milk allergy, soy protein allergy, fish protein allergy, egg protein allergy, lactose intolerance, galactosemia);
- Currently participating or having participated in another clinical trial during the last month.
- Infants whose legal representatives have psychological or linguistic incapability to sign the informed consent form
- Reasons to presume that parents are unable to meet the study plan requirements (e.g. impossibility to contact study representatives in case of emergency, drug addiction etc.)
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 200040
About this study
The purpose of this study is to evaluate the effect of the probiotic product on the GI tract flora composition.
- Conditions
- Gastrointestinal Tract Flora Composition
- Being tested
- Biostime probiotics sachet children's formula, Biostime probiotics sachet children's formula（placebo）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biostime probiotics sachet children's formulaDrug
Biostime probiotics sachet children's formula,1.5g Oral Single dose
Biostime probiotics sachet children's formula（placebo）Drug
Biostime probiotics sachet children's formula（placebo）,1.5g Oral Single dose
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Active comparator | Biostime probiotics sachet children's formula, 1.5g/d/sachet, administrated during the consumption of the first feeding-bottle of the day. Duration: 4 weeks Receives: Drug: Biostime probiotics sachet children's formula |
| Probiotics simulation | Placebo comparator | Biostime probiotics sachet children's formula（placebo）, 1.5g/d/sachet, administrated during the consumption of the first feeding-bottle of the day. Duration: 4 weeks Receives: Drug: Biostime probiotics sachet children's formula（placebo） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving the modulatory effect on the GI tract flora composition after the intervention.
GI tract flora include Bifidobacterium, Lactobacillus, Clostridium perfringens, Enterococcus, Enterobacter, Bacteroides. Modulatory effect of GI tract flora composition was defined as two definitions. The first definition is that Lactobacillus and/or Bifidobacterium increases significantly, Clostridium perfringens decreases or has no change and Enterococcus, Enterobacter, Bacteroides has no obvious change. The other is that Lactobacillus and/or Bifidobacterium increases significantly, Clostridium perfringens decreases or has no change, Enterobacter and/or Enterococcus, Bacteroides increases significantly, but the amplification less than Lactobacillus/Bifidobacterium.
Measured: From Baseline to week 4
Change of Lactobacillus helveticuspopulations in stool
Measured: From Baseline to week 4
Secondary outcomes (12)
average daily number of stools
Measured: From Baseline to week 4
Aaverage daily Infant Stool Form scores consistency
Measured: From Baseline to week 4
Average weekly Infant Stool Form scores amount
Measured: From Baseline to week 4
Average weekly Infant Stool Form scores color
Measured: From Baseline to week 4
Average daily number of crying episodes
Measured: From Baseline to week 4
Average daily duration of crying episodes
Measured: From Baseline to week 4
sIgA antibody levels in stool
Measured: From Baseline to week 4
sIgA antibody levels in saliva
Measured: From Baseline to week 4
change in infant weight
Measured: From Baseline to week 4
change in infant length
Measured: From Baseline to week 4
change in infant head circumference
Measured: From Baseline to week 4
The number of AE and SAE
Measured: From Baseline to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Tract Flora CompositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biostime Institute of Nutrition and Care
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317406
- Sponsor's protocol ID
- PEC13036
- Status last verified
- Jul 2016
- First submitted
- 8 Dec 2014
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics on the Digestibility and Immunity in Infants
- ClinicalTrials.gov ID
- NCT02317406
- Acronym / sponsor ID
- PEC13036
- Conditions
- Gastrointestinal Tract Flora Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Biostime Institute of Nutrition and CareUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of the probiotic product on the GI tract flora composition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Active comparator | Drug: Biostime probiotics sachet children's formulaBiostime probiotics sachet children's formula, 1.5g/d/sachet, administrated during the consumption of the first feeding-bottle of the day. Duration: 4 weeks |
| Probiotics simulation | Placebo comparator | Drug: Biostime probiotics sachet children's formula（placebo）Biostime probiotics sachet children's formula（placebo）, 1.5g/d/sachet, administrated during the consumption of the first feeding-bottle of the day. Duration: 4 weeks |
Who may qualify
- Ages
- 4 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Healthy infants;
- Single birth;
- Gestational age ≥ 37 weeks (=non-preterm infant, WHO);
- Birth weight: > 2500g
- Appropriate weight between P20-P80 in accordance with the weight percentile standards of the children ages 0 to 6 years in Shanghai urban areas at inclusion visit ;
Key exclusion criteria (14 listed)
- Congenital illness or malformation;
- Significant pre-natal and/or post-natal disease;
- Mothers with metabolic or chronic diseases;
- Infants with allergic constitution and sensitive to the probiotics (CCDC recommendations);
- Infants with serious diseases, such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system diseases and internal secretion diseases, and those with mental disorder (CCDC recommendations);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biostime probiotics sachet children's formulaBiostime probiotics sachet children's formula,1.5g Oral Single dose | Drug | Probiotics |
| Biostime probiotics sachet children's formula（placebo）Biostime probiotics sachet children's formula（placebo）,1.5g Oral Single dose | Drug | Probiotics simulation |
Primary outcome
Proportion of Participants Achieving the modulatory effect on the GI tract flora composition after the intervention.
Time frame: From Baseline to week 4
GI tract flora include Bifidobacterium, Lactobacillus, Clostridium perfringens, Enterococcus, Enterobacter, Bacteroides. Modulatory effect of GI tract flora composition was defined as two definitions. The first definition is that Lactobacillus and/or Bifidobacterium increases significantly, Clostridium perfringens decreases or has no change and Enterococcus, Enterobacter, Bacteroides has no obvious change. The other is that Lactobacillus and/or Bifidobacterium increases significantly, Clostridium perfringens decreases or has no change, Enterobacter and/or Enterococcus, Bacteroides increases significantly, but the amplification less than Lactobacillus/Bifidobacterium.
Change of Lactobacillus helveticuspopulations in stool
Time frame: From Baseline to week 4
12 secondary outcomes
average daily number of stools
Time frame: From Baseline to week 4
Aaverage daily Infant Stool Form scores consistency
Time frame: From Baseline to week 4
Average weekly Infant Stool Form scores amount
Time frame: From Baseline to week 4
Average weekly Infant Stool Form scores color
Time frame: From Baseline to week 4
Average daily number of crying episodes
Time frame: From Baseline to week 4
Average daily duration of crying episodes
Time frame: From Baseline to week 4
sIgA antibody levels in stool
Time frame: From Baseline to week 4
sIgA antibody levels in saliva
Time frame: From Baseline to week 4
change in infant weight
Time frame: From Baseline to week 4
change in infant length
Time frame: From Baseline to week 4
change in infant head circumference
Time frame: From Baseline to week 4
The number of AE and SAE
Time frame: From Baseline to week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biostime probiotics sachet children's formula in people with Gastrointestinal Tract Flora Composition, run by Biostime Institute of Nutrition and Care at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving the modulatory effect on the GI tract flora composition after the intervention. (time frame: From Baseline to week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016.