Growth RetardationNCT02716935
Prebiotics and Microbiota Composition and Functionality in Rural Burkinabe Infants
A study testing Fortified lipid based nutrient supplement and lipid based nutrient supplement in people with Growth Retardation and Infant Morbidity, run by University Ghent at 1 site in Burkina Faso.
Trial summary
The purpose of this study is to assess the effect of a mixture of prebiotics included in a food supplement on microbiota diversity and functionality, and to explore its subsequent effects on linear growth velocity and morbidity. Read more about this study
- Who is it for?
- Ages 24 to 26 weeksHealthy volunteers can take part
- Conditions the study is for
- Growth Retardation, Infant Morbidity
- What is being tested?
- Fortified lipid based nutrient supplement and lipid based nutrient supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Mar 2016to Nov 2019
- 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 24 to 26 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6-6.5 month old infants
- Weight for height and height for age z-score above -2
- Permanent resident of the area and not intending to move for the next 6 months for more than a week
- No chronic antibiotic treatment
- Exempt of any current serious illness
- Still breastfed.
Who cannot join
- Moderate or severe malnutrition (weight for height or height for age z-score below -2)
- non-permanent residence in the study area,
- the presence of any congenital anomalies in the child or mental/physical disease of the mother that can interfere with child feeding
- a chronic antibiotic treatment i.e. more than 6 weeks treatment at the time of enrolment
- a history of allergy to a constituent of the supplement
- a serious current illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Supplementation With LNS Fortified With a Mixture of FOS and Inulin on Gut Microbiota Diversity and Functionality and Its Repercussion on Growth and Morbidity During Infancy in Rural Burkina Faso
The purpose of this study is to assess the effect of a mixture of prebiotics included in a food supplement on microbiota diversity and functionality, and to explore its subsequent effects on linear growth velocity and morbidity.
Read the detailed description
The central role of gut microbiota in immunity and nutritional homeostasis is now acknowledged, albeit not fully understood. Gut microbiota composition imbalances have been found in malnourished children, which were not restored by nutritional interventions as currently conducted. Therefore, the necessity to design more complete nutritional interventions that include gut health has been advised by expert committees.
Prebiotics are compound that selectively enhance the growth of beneficial gut bacteria. They have been recommended and used in infant formula and weaning cereals resulting in gut microbiota resembling that of breastfed infants in formula fed infants in developed countries. A healthy gut microbiota was shown to be associated with enhanced growth patterns and decreased morbidity in children in developed countries. Evidence of such outcome is lacking in developing countries, yet such results would be particularly valuable for children from these settings, living in rather poor sanitary conditions in an environment characterized with high infectious disease load, conditions that mostly explain the high prevalence of chronic malnutrition. This study aims to assess the effect of a 6 months' supplementation with a lipid based nutrient supplement fortified with fructo-oligosaccharides and inulin on microbiota diversity and functionality in rural Burkinabe infants, and to explore its subsequent effects on linear growth velocity and morbidity.
- Conditions
- Growth Retardation, Infant Morbidity
- Being tested
- Fortified lipid based nutrient supplement, lipid based nutrient supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified lipid based nutrient supplementDietary supplement
6 months intervention: participant will take a daily dose of 20g supplement. The product contains 3 g of a mixture (1:1) of inulin and fructan-oligosaccharide
lipid based nutrient supplementDietary supplement
Dietary Supplement: lipid based nutrient supplement (Nutributter) 6 months intervention: participant will take a daily dose of 20g supplement.
| Study group | Role | What they receive |
|---|---|---|
| Fortified lipid based nutrient supplement | Experimental | lipid based nutrient supplement (Nutributter) fortified with fructo-oligosaccharides and inulin Receives: Dietary Supplement: Fortified lipid based nutrient supplement |
| lipid based nutrient supplement | Active comparator | lipid based nutrient supplement (Nutributter) Receives: Dietary Supplement: lipid based nutrient supplement |
| non intervention group | No intervention | This group will not be supplemented |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal microbiota range-weighted richness
Composition of fecal microbiota will be determined by Illumina sequencing from which range-weighted richness will be calculated
Measured: 6 months
Mean concentration of short-chain fatty acids in stool
Concentration of short-chain fatty acids (acetate, butyrate and propionate) will be measured by Gas Chromatography
Measured: 6 months
Secondary outcomes (11)
Frequency of digestive intolerance symptoms (flatulence, abdominal pain, regurgitation, vomiting, or diarrhea)
Digestive intolerance symptoms will be recalled.
Measured: once every week during the first month of supplementation
Stool consistency
Stool consistency will be recalled
Measured: Once every week during the first month of supplementation
Stool frequency per day
Stool frequency per day will be recalled.
Measured: 6 months
Mean stool pH
Stool pH will be measured once a week with pH sticks by a study nurse
Measured: once every week during the first month of supplementation
Calprotectin concentration in stool
Concentration of calprotectin will be measured by ELISA
Measured: at inclusion, 3 months and 6months after inclusion
Infant linear growth velocity
Linear growth velocity will be determined using the difference between 2 length measures over the follow up time in months and expressed in millimeters/ month
Measured: once a month during 6 months
Infant ponderal growth velocity
Ponderal growth velocity will be determined using the difference between 2 weight measures over the follow up time in month and expressed in grams/ month. Infant's weight will be measured at inclusion and once a month during 6 months
Measured: once a month during 6 months
Cumulative morbidity
Cumulative morbidity of (malaria, gastro-intestinal tract infection, acute respiratory tract infection, acute otitis) will be assessed one a week by a study nurse
Measured: Starting from inclusion, weekly during a follow-up of 6 months
Infant's intestinal permeability
Intestinal permeability will be assessed using a mannitol-lactulose test
Measured: at inclusion, 3 months and 6 months after inclusion
Residual fecal microbiota range-weighted richness
Composition of fecal microbiota will be determined by Illumina sequencing, from which range-weighted richness will be calculated
Measured: 3 months and 6 months
Residual concentration of short-chain fatty acids in stool
Concentration of short chain fatty acids (acetate, butyrate and propionate) will be measured by Gas Chromatography
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion24 Apr 2018
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth RetardationStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche en Sciences de la Sante, Burkina Faso, Nutriset
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716935
- Sponsor's protocol ID
- University Ghent
- Status last verified
- Jun 2020
- First submitted
- 1 Feb 2016
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Upon publication of the main findings, data will be shared on a public repository and made publicly available on request as per recently published guidance and regulations (BMJ 2016;352:i255)
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplementation With LNS Fortified With a Mixture of FOS and Inulin on Gut Microbiota Diversity and Functionality and Its Repercussion on Growth and Morbidity During Infancy in Rural Burkina Faso
- ClinicalTrials.gov ID
- NCT02716935
- Acronym / sponsor ID
- University Ghent
- Conditions
- Growth Retardation, Infant Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Institut de Recherche en Sciences de la Sante, Burkina Faso, Nutriset
- Study start
- Mar 2016
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 23 Mar 2016 (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 assess the effect of a mixture of prebiotics included in a food supplement on microbiota diversity and functionality, and to explore its subsequent effects on linear growth velocity and morbidity.
Detailed description
The central role of gut microbiota in immunity and nutritional homeostasis is now acknowledged, albeit not fully understood. Gut microbiota composition imbalances have been found in malnourished children, which were not restored by nutritional interventions as currently conducted. Therefore, the necessity to design more complete nutritional interventions that include gut health has been advised by expert committees.
Prebiotics are compound that selectively enhance the growth of beneficial gut bacteria. They have been recommended and used in infant formula and weaning cereals resulting in gut microbiota resembling that of breastfed infants in formula fed infants in developed countries. A healthy gut microbiota was shown to be associated with enhanced growth patterns and decreased morbidity in children in developed countries. Evidence of such outcome is lacking in developing countries, yet such results would be particularly valuable for children from these settings, living in rather poor sanitary conditions in an environment characterized with high infectious disease load, conditions that mostly explain the high prevalence of chronic malnutrition. This study aims to assess the effect of a 6 months' supplementation with a lipid based nutrient supplement fortified with fructo-oligosaccharides and inulin on microbiota diversity and functionality in rural Burkinabe infants, and to explore its subsequent effects on linear growth velocity and morbidity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fortified lipid based nutrient supplement | Experimental | Dietary Supplement: Fortified lipid based nutrient supplementlipid based nutrient supplement (Nutributter) fortified with fructo-oligosaccharides and inulin |
| lipid based nutrient supplement | Active comparator | Dietary Supplement: lipid based nutrient supplementlipid based nutrient supplement (Nutributter) |
| non intervention group | No intervention | –This group will not be supplemented |
Who may qualify
- Ages
- 24 to 26 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 6-6.5 month old infants
- Weight for height and height for age z-score above -2
- Permanent resident of the area and not intending to move for the next 6 months for more than a week
- No chronic antibiotic treatment
- Exempt of any current serious illness
Key exclusion criteria (6 listed)
- Moderate or severe malnutrition (weight for height or height for age z-score below -2)
- non-permanent residence in the study area,
- the presence of any congenital anomalies in the child or mental/physical disease of the mother that can interfere with child feeding
- a chronic antibiotic treatment i.e. more than 6 weeks treatment at the time of enrolment
- a history of allergy to a constituent of the supplement
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 |
|---|---|---|
| Fortified lipid based nutrient supplement6 months intervention: participant will take a daily dose of 20g supplement. The product contains 3 g of a mixture (1:1) of inulin and fructan-oligosaccharide | Dietary supplement | Fortified lipid based nutrient supplement |
| lipid based nutrient supplementDietary Supplement: lipid based nutrient supplement (Nutributter) 6 months intervention: participant will take a daily dose of 20g supplement. | Dietary supplement | lipid based nutrient supplement |
Primary outcome
Fecal microbiota range-weighted richness
Time frame: 6 months
Composition of fecal microbiota will be determined by Illumina sequencing from which range-weighted richness will be calculated
Mean concentration of short-chain fatty acids in stool
Time frame: 6 months
Concentration of short-chain fatty acids (acetate, butyrate and propionate) will be measured by Gas Chromatography
11 secondary outcomes
Frequency of digestive intolerance symptoms (flatulence, abdominal pain, regurgitation, vomiting, or diarrhea)
Time frame: once every week during the first month of supplementation
Stool consistency
Time frame: Once every week during the first month of supplementation
Stool frequency per day
Time frame: 6 months
Mean stool pH
Time frame: once every week during the first month of supplementation
Calprotectin concentration in stool
Time frame: at inclusion, 3 months and 6months after inclusion
Infant linear growth velocity
Time frame: once a month during 6 months
Infant ponderal growth velocity
Time frame: once a month during 6 months
Cumulative morbidity
Time frame: Starting from inclusion, weekly during a follow-up of 6 months
Infant's intestinal permeability
Time frame: at inclusion, 3 months and 6 months after inclusion
Residual fecal microbiota range-weighted richness
Time frame: 3 months and 6 months
Residual concentration of short-chain fatty acids in stool
Time frame: 3 months and 6 months
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 11 Jun 2020.
- Individual participant dataSharing planned: Yes. Upon publication of the main findings, data will be shared on a public repository and made publicly available on request as per recently published guidance and regulations (BMJ 2016;352:i255)
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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 Fortified lipid based nutrient supplement and lipid based nutrient supplement in people with Growth Retardation and Infant Morbidity, run by University Ghent at 1 site in Burkina Faso.
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 6 inclusion and 6 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 11 Jun 2020. 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 Burkina Faso. 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. 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?
Fecal microbiota range-weighted richness (time frame: 6 months). 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 11 Jun 2020.