Severe MalnutritionNCT02413905
Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition
An observational study of Severe Malnutrition and Malnutrition, run by Institut Hospitalo-Universitaire Méditerranée Infection at 2 sites in 2 countries.
Trial summary
The investigators performed two case-control studies in Niger and Senegal analysing fecal microbiota to characterize the specificity of the gut microbiota alteration associated with severe acute malnutrition (SAM). Read more about this study
- Who is it for?
- Ages Up to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Severe Malnutrition, Malnutrition, Infant Nutrition Disorders
- What is being tested?
- Stool samples
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2014to Mar 2015
- Phase
- Observational
- 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 Up to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children from Niamey and Dakar, Senegal
Who may be able to join
- Children aged 0-59 months of varying nutritional status from Niamey (Niger) and Dakar (Senegal).
Who cannot join
- Absence of parent or patient consent, antibiotic administration <2 months before stool collection and insufficient fecal amount. Exclusion criteria for controls included any form of malnutrition, presence of fever, acute respiratory infection (cough), acute or chronic diarrhea in the previous 4 weeks. Symptoms and complications of malnutrition (cough, fever, diarrhoea, vomiting) nor other form of malnutrition (moderate to severe stunting and underweight) were not a reason of exclusion for cases since they are considered as direct consequence and part of severe acute malnutrition.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The investigators performed two case-control studies in Niger and Senegal analysing fecal microbiota to characterize the specificity of the gut microbiota alteration associated with severe acute malnutrition (SAM).
Read the detailed description
Fecal samples of cases (severe acute malnutrition (SAM) ascertained according to the WHO definition) and controls (asymptomatic healthy children ascertained by clinical and anthropometric criteria) were analysed by v3v4 16S rRNA sequencing, redox and pH measurement and using specific polymerase chain reaction targeting Methanobrevibacter smithii and Bacteroides thetaiotaomicron. Based on the literature and oxydative stress reported in SAM, the investigators tested if the proportion of aerotolerant prokaryotes is increased among gut prokaryotes enriched in SAM in comparison to prokaryotes enriched in controls. The investigators further linked this to fecal redox potential and assessed the total number of bacteria in feces by flux cytometry.
- Conditions
- Severe Malnutrition, Malnutrition, Infant Nutrition Disorders, Child Nutrition Disorders, Kwashiorkor, Marasmus
- Being tested
- Stool samples
- Medical subject headings
- Malnutrition, Infant Nutrition Disorders, Child Nutrition Disorders, Kwashiorkor, Protein-Energy Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool samplesBiological
Stool samples
| Study group | Role | What they receive |
|---|---|---|
| Senegal | Stool samples on Children with and without severe acute malnutrition in Senegal recruited in 3 locations (Dakar, Dielmo and Ndiop) Receives: Biological: Stool samples | |
| Niger | Stool samples Children with and without severe acute malnutrition in Niger recruited in Niamey Receives: Biological: Stool samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerotolerant Odds ratio (AOR)
AOR = (number of aerotolerant prokaryotes enriched in the gut of children with SAM * number of obligate anaerobic prokaryotes enriched in controls)/(number of aerotolerant prokaryotes enriched in controls * number of obligate anaerobic prokaryotes enriched in children with SAM)
Measured: 1 day (Participants were not followed as this is a case-contol study only clinical and anthropometric data and fecal samples were collected the day of inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe MalnutritionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Hospitalo-Universitaire Méditerranée Infection
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu Million, Study chair, Assistance publique des Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413905
- Sponsor's protocol ID
- SAMGUT
- Status last verified
- Apr 2015
- First submitted
- 30 Mar 2015
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition
- ClinicalTrials.gov ID
- NCT02413905
- Acronym / sponsor ID
- SAMGUT
- Conditions
- Severe Malnutrition, Malnutrition, Infant Nutrition Disorders, Child Nutrition Disorders, Kwashiorkor, Marasmus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut Hospitalo-Universitaire Méditerranée InfectionUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 10 Apr 2015 (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 investigators performed two case-control studies in Niger and Senegal analysing fecal microbiota to characterize the specificity of the gut microbiota alteration associated with severe acute malnutrition (SAM).
Detailed description
Fecal samples of cases (severe acute malnutrition (SAM) ascertained according to the WHO definition) and controls (asymptomatic healthy children ascertained by clinical and anthropometric criteria) were analysed by v3v4 16S rRNA sequencing, redox and pH measurement and using specific polymerase chain reaction targeting Methanobrevibacter smithii and Bacteroides thetaiotaomicron. Based on the literature and oxydative stress reported in SAM, the investigators tested if the proportion of aerotolerant prokaryotes is increased among gut prokaryotes enriched in SAM in comparison to prokaryotes enriched in controls. The investigators further linked this to fecal redox potential and assessed the total number of bacteria in feces by flux cytometry.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Senegal | – | Biological: Stool samplesStool samples on Children with and without severe acute malnutrition in Senegal recruited in 3 locations (Dakar, Dielmo and Ndiop) |
| Niger | – | Biological: Stool samplesStool samples Children with and without severe acute malnutrition in Niger recruited in Niamey |
Who may qualify
- Ages
- Up to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children from Niamey and Dakar, Senegal
Key inclusion criteria (1 listed)
- Children aged 0-59 months of varying nutritional status from Niamey (Niger) and Dakar (Senegal).
Key exclusion criteria (1 listed)
- Absence of parent or patient consent, antibiotic administration <2 months before stool collection and insufficient fecal amount. Exclusion criteria for controls included any form of malnutrition, presence of fever, acute respiratory infection (cough), acute or chronic diarrhea in the previous 4 weeks. Symptoms and complications of malnutrition (cough, fever, diarrhoea, vomiting) nor other form of malnutrition (moderate to severe stunting and underweight) were not a reason of exclusion for cases since they are considered as direct consequence and part of severe acute malnutrition.
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 |
|---|---|---|
| Stool samplesStool samples | Biological | Niger, Senegal |
Primary outcome
Aerotolerant Odds ratio (AOR)
Time frame: 1 day (Participants were not followed as this is a case-contol study only clinical and anthropometric data and fecal samples were collected the day of inclusion)
AOR = (number of aerotolerant prokaryotes enriched in the gut of children with SAM * number of obligate anaerobic prokaryotes enriched in controls)/(number of aerotolerant prokaryotes enriched in controls * number of obligate anaerobic prokaryotes enriched in children with SAM)
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 10 Apr 2015.
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The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients
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Opportunistic Pneumococcal Immunisation Trial in MALnutrition
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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.
Matthieu Million study chair
Assistance publique des Hôpitaux de Marseille
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Malnutrition and Malnutrition, run by Institut Hospitalo-Universitaire Méditerranée Infection at 2 sites in 2 countries.
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 1 inclusion and 1 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 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Niger, Senegal. 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?
Aerotolerant Odds ratio (AOR) (time frame: 1 day (Participants were not followed as this is a case-contol study only clinical and anthropometric data and fecal samples were collected the day of inclusion)). 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 10 Apr 2015.