Child MalnutritionP-MAMNCT06155474
Effects of Prebiotics on Metagenomic Diversity and Abundance in Young Children With Acute Malnutrition
A study testing Prebiotic galacto-oligosaccharide (GOS) Powder, Starch Only and RUTF + Starch in people with Child Malnutrition, run by University of the Punjab at 1 site in Pakistan.
Trial summary
Malnutrition is a major global public health issue, contributing to poor health and early morbidities in children under five, particularly in developing countries. In 2021, 5 million children died worldwide due to infectious diseases or malnutrition, with Pakistan having the highest under-five mortality rate. Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Malnutrition
- What is being tested?
- Prebiotic galacto-oligosaccharide (GOS) Powder, Starch Only and RUTF + Starch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 1 Jun 2024
- 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 6 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Acute malnutrition without complications, as defined by the World Health Organization (i.e., children with mid-upper arm circumference (MUAC) <115 mm or weight-for-height z-score <-3 or grade 1-2 bilateral edema who will be clinically well and alert with good appetite);
- Parental consent for the child to participate.
- Healthy children without any chronic or acute illness
Who cannot join
- Presence of any complications of severe malnutrition (severe dehydration, severe anemia, severe pitting edema, anorexia, hypothermia, high pyrexia, acute lower respiratory infection, or hypoglycemia) or immunocompromised.
- Children on antibiotic treatment for any disease in the last 3 months will be excluded.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Public Health, University of the Punjab
Lahore, 54500
Javeria Saleem, PhD, +923004366011, js.iscs@pu.edu.pk
Muhammad Salman Butt, PhD, 00923328454549, sames_butt@hotmail.com
About this study
Official title: Effects of Prebiotics on Metagenomic Diversity and Abundance in Young Children With Acute Malnutrition: A Double-blinded Randomised Controlled Trial (PMAM)
Malnutrition is a major global public health issue, contributing to poor health and early morbidities in children under five, particularly in developing countries. In 2021, 5 million children died worldwide due to infectious diseases or malnutrition, with Pakistan having the highest under-five mortality rate. With a population of approximately 229 million, Pakistan is the fifth most populous country in the world. In Pakistan, under-five mortality is 63.3 per 1000 live births which has declined from 139.8 in 1990 to 63.3 in 2021 (WHO, 2022, UNICEF, 2023). The monsoon season's massive flooding in Pakistan has worsened the humanitarian situation, endangering the already vulnerable population. UNICEF reports high rates of acute malnutrition, political instability, economic decline, and coronavirus disease 2019 effects. However, there is limited evidence on the efficacy of probiotics for infants in Pakistan.
Metagenomics is the study of microorganisms' genomes, examining all microorganisms in an ecological site's genomes. It involves extracting and sequencing DNA using high-throughput techniques. Scientists can identify genes with significant features using computer analysis. The distal intestine contains around one trillion organisms per milliliter of luminal contents, and understanding their potential for energy and nutrient harvest is crucial in malnourished individuals.
Read more
Alpha diversity is the analysis of species diversity in a sample, measured by observed species index, Chao1 index, Shannon index, Simpson index, and good-coverage index. It is proportional to the first four values and indicates less undiscovered species. The distal intestine contains around one trillion organisms per milliliter of luminal contents, with an increased capacity for energy harvest in malnourished individuals.
The present study aims to measure the following objectives. i. -To estimate the microbiome degree of diversity among malnutrition children micro-biota defined by 16 Svedberg (S) ribosomal ribonucleic acid gene sequencing.
ii. -To evaluate the interpersonal differences in the structure and functioning of the gut microbiome that affect a person's vulnerability to malnutrition.
iii. -To determine how microbiomes are shaped by host genotypes, environmental exposures, including exposure to malnutrition in children mothers, and other family members, nutritional status, and lifestyles, including diet.
Read the detailed description
Metagenomics is the study of microorganisms' genomes through the direct extraction and cloning of their DNA from a collection of microorganisms, also known as environmental and community genomics. The examination of all the microorganisms in an ecological site's genomes, the majority of which cannot be produced under standard laboratory conditions, is called metagenomics. In order to achieve this, the site's microbial population must first be removed, and then its DNA must be isolated and sequenced using high-throughput techniques. Scientists may identify genes with significant features, such as virulence genes or genes encoding enzymes of commercial significance, using computer analysis of a sequence.
Around one trillion organisms per milliliter of luminal contents are found in the distal intestine, where the majority of these bacteria are found. It is essential to describe the microbiota and its microbiome in malnourished persons and to define their potential to harvest energy and nutrients in light of the discovery that the intestinal microbiota/ microbiome linked with obesity has an increased capacity for energy harvest.
Deficiency of iron has been recognized in malnourished children. Iron present in RUTF is not sufficient to elevate "circulating levels of ferritin into the optimal physiological range. Prebiotics has been proven to have anti-inflammatory and antimicrobial actions that might enhance response to standard therapy for severe acute malnutrition (SAM), Targeting the gut microbiota through the use of Prebiotics as part of treatment in malnourished children may present an affordable and cost-effective strategy in the prevention and also in the treatment Fortifying the microbiota with Prebiotics could enhance energy and may protect against diarrhoea. However, randomized controlled trials evaluating the effects of prebiotic supplementation in children with severe acute malnutrition have not previously been done. So clinical evidence is lacking and cannot be translated into clinical practice.
Content of "Ready-to-use therapeutic food" may not be optimal to support weight gain a in children with severe acute malnutrition. Further trials are required to conclude whether Prebiotics containing Galactooligosaccharides supplement can improve weight gain in children with severe acute malnutrition in other settings.
Trial Objectives and Endpoints Trial Objectives
- To estimate the microbiome degree of diversity among malnutrition children micro-biota defined by 16 Svedberg (S) ribosomal ribonucleic acid gene sequencing.
- To evaluate the interpersonal differences in the structure and functioning of the gut microbiome that affect a person's vulnerability to malnutrition.
- To determine how microbiomes are shaped by host genotypes, environmental exposures, including exposure to malnutrition in children mothers, and other family members, nutritional status, and lifestyles, including diet.
- Conditions
- Child Malnutrition
- Being tested
- Prebiotic galacto-oligosaccharide (GOS) Powder, Starch Only, RUTF + Starch
- Keywords
- malnutrition, Metagenomics, Micro-biota
- Medical subject headings
- Child Nutrition Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic galacto-oligosaccharide (GOS) PowderDietary supplement
Prebiotic GOS Powder is a galacto-oligosaccharide ingredient low in mono-sugars. Scientific studies have shown positive effects of oligosaccharides, among which galacto-oligosaccharides, on growth of bifidobacterial, stool consistency bowel function and transit time, support of natural defenses and mineral absorption.
The product mainly consists of 97% dry matter with 69% prebiotic GOS, 23% lactose and 5% glucose and galactose as monosaccharides. These prebiotics have β-(4) glycosidic linkages and have been proven as safe product
Starch OnlyDietary supplement
The Starch Solution is a low-fat diet.
RUTF + StarchDietary supplement
ready-to-use therapeutic food and The Starch Solution is a low-fat diet.
| Study group | Role | What they receive |
|---|---|---|
| Healthy/Control (Starch) | Placebo comparator | The Healthy Controls will be given starch packed in the same way as the active prebiotics Receives: Dietary Supplement: Starch Only |
| Malnutrition (RUTF + Starch) | Experimental | The Malnutrition group with RUTF and Starch only. The RUTF will be given as per the WHO guidelines Receives: Dietary Supplement: RUTF + Starch |
| Malnutrition (RUTF + prebiotics) | Active comparator | The Malnutrition group with RUTF and Prebiotic only. The RUTF will be given as per the WHO guidelines Receives: Dietary Supplement: Prebiotic galacto-oligosaccharide (GOS) Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome diversity
Microbiome diversity examination among malnourished children using 16 Svedberg (S) ribosomal ribonucleic acid gene sequencing. The microbiome diversity index measures the diversity of microbial species in malnourished children's gut microbiota, comparing it to reference or control populations. Higher values indicate greater diversity, providing insights into malnutrition's impact on gut microbiota composition.
Measured: 8 Weeks
Secondary outcomes (3)
Anthropometric Measurements
Change in the mean weight-for-height/length z-score in children with complicated severe acute malnutrition who have been taking prebiotics supplementation for 8 weeks.
Measured: 8 Weeks
Neurodevelopment Assessment
Impact assessment of prebiotic supplementation on children's neurodevelopment using the Malawi Development Assessment tool
Measured: 8 Weeks
Muscle mass accumulation
The study investigates the impact of prebiotic consumption on body composition changes using the Body Stat Analyzer as a quantitative measurement tool.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prebiotic
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Punjab
- Sponsor type
- University, hospital or other
- Collaborators
- University of Veterinary and Animal Sciences, Lahore - Pakistan
- Responsible party
- Principal investigator, Dr. Javeria Saleem, University of the Punjab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155474
- Sponsor's protocol ID
- D/137/FIMS
- Acronym
- P-MAM
- Status last verified
- Nov 2023
- First submitted
- 17 Oct 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saleem J, Zakar R, Iqbal S, Arshad M, Shahzad R, Batool M, Nawaz M, Butt MS, Fischer F. Effects of prebiotics on microbial diversity and abundance in young children with acute malnutrition: study protocol for a multi-centered, double-blinded randomized controlled trial. Trials. 2024 Nov 26;25(1):798. doi: 10.1186/s13063-024-08647-z.
PubMed 39593072
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prebiotics on Metagenomic Diversity and Abundance in Young Children With Acute Malnutrition: A Double-blinded Randomised Controlled Trial (PMAM)
- ClinicalTrials.gov ID
- NCT06155474
- Acronym / sponsor ID
- P-MAM / D/137/FIMS
- Conditions
- Child Malnutrition
- Keywords
- malnutrition, Metagenomics, Micro-biota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of the PunjabUniversity, hospital or other
- Collaborators
- University of Veterinary and Animal Sciences, Lahore - Pakistan
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 4 Dec 2023 (actual)
- 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.
Malnutrition is a major global public health issue, contributing to poor health and early morbidities in children under five, particularly in developing countries. In 2021, 5 million children died worldwide due to infectious diseases or malnutrition, with Pakistan having the highest under-five mortality rate. With a population of approximately 229 million, Pakistan is the fifth most populous country in the world. In Pakistan, under-five mortality is 63.3 per 1000 live births which has declined from 139.8 in 1990 to 63.3 in 2021 (WHO, 2022, UNICEF, 2023). The monsoon season's massive flooding in Pakistan has worsened the humanitarian situation, endangering the already vulnerable population. UNICEF reports high rates of acute malnutrition, political instability, economic decline, and coronavirus disease 2019 effects. However, there is limited evidence on the efficacy of probiotics for infants in Pakistan.
Metagenomics is the study of microorganisms' genomes, examining all microorganisms in an ecological site's genomes. It involves extracting and sequencing DNA using high-throughput techniques. Scientists can identify genes with significant features using computer analysis. The distal intestine contains around one trillion organisms per milliliter of luminal contents, and understanding their potential for energy and nutrient harvest is crucial in malnourished individuals.
Alpha diversity is the analysis of species diversity in a sample, measured by observed species index, Chao1 index, Shannon index, Simpson index, and good-coverage index. It is proportional to the first four values and indicates less undiscovered species. The distal intestine contains around one trillion organisms per milliliter of luminal contents, with an increased capacity for energy harvest in malnourished individuals.
The present study aims to measure the following objectives. i. -To estimate the microbiome degree of diversity among malnutrition children micro-biota defined by 16 Svedberg (S) ribosomal ribonucleic acid gene sequencing.
ii. -To evaluate the interpersonal differences in the structure and functioning of the gut microbiome that affect a person's vulnerability to malnutrition.
iii. -To determine how microbiomes are shaped by host genotypes, environmental exposures, including exposure to malnutrition in children mothers, and other family members, nutritional status, and lifestyles, including diet.
Detailed description
Metagenomics is the study of microorganisms' genomes through the direct extraction and cloning of their DNA from a collection of microorganisms, also known as environmental and community genomics. The examination of all the microorganisms in an ecological site's genomes, the majority of which cannot be produced under standard laboratory conditions, is called metagenomics. In order to achieve this, the site's microbial population must first be removed, and then its DNA must be isolated and sequenced using high-throughput techniques. Scientists may identify genes with significant features, such as virulence genes or genes encoding enzymes of commercial significance, using computer analysis of a sequence.
Around one trillion organisms per milliliter of luminal contents are found in the distal intestine, where the majority of these bacteria are found. It is essential to describe the microbiota and its microbiome in malnourished persons and to define their potential to harvest energy and nutrients in light of the discovery that the intestinal microbiota/ microbiome linked with obesity has an increased capacity for energy harvest.
Deficiency of iron has been recognized in malnourished children. Iron present in RUTF is not sufficient to elevate "circulating levels of ferritin into the optimal physiological range. Prebiotics has been proven to have anti-inflammatory and antimicrobial actions that might enhance response to standard therapy for severe acute malnutrition (SAM), Targeting the gut microbiota through the use of Prebiotics as part of treatment in malnourished children may present an affordable and cost-effective strategy in the prevention and also in the treatment Fortifying the microbiota with Prebiotics could enhance energy and may protect against diarrhoea. However, randomized controlled trials evaluating the effects of prebiotic supplementation in children with severe acute malnutrition have not previously been done. So clinical evidence is lacking and cannot be translated into clinical practice.
Content of "Ready-to-use therapeutic food" may not be optimal to support weight gain a in children with severe acute malnutrition. Further trials are required to conclude whether Prebiotics containing Galactooligosaccharides supplement can improve weight gain in children with severe acute malnutrition in other settings.
Trial Objectives and Endpoints Trial Objectives
- To estimate the microbiome degree of diversity among malnutrition children micro-biota defined by 16 Svedberg (S) ribosomal ribonucleic acid gene sequencing.
- To evaluate the interpersonal differences in the structure and functioning of the gut microbiome that affect a person's vulnerability to malnutrition.
- To determine how microbiomes are shaped by host genotypes, environmental exposures, including exposure to malnutrition in children mothers, and other family members, nutritional status, and lifestyles, including diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Prebiotic
| Arm | Type | Receives |
|---|---|---|
| Healthy/Control (Starch) | Placebo comparator | Dietary Supplement: Starch OnlyThe Healthy Controls will be given starch packed in the same way as the active prebiotics |
| Malnutrition (RUTF + Starch) | Experimental | Dietary Supplement: RUTF + StarchThe Malnutrition group with RUTF and Starch only. The RUTF will be given as per the WHO guidelines |
| Malnutrition (RUTF + prebiotics) | Active comparator | Dietary Supplement: Prebiotic galacto-oligosaccharide (GOS) PowderThe Malnutrition group with RUTF and Prebiotic only. The RUTF will be given as per the WHO guidelines |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Acute malnutrition without complications, as defined by the World Health Organization (i.e., children with mid-upper arm circumference (MUAC) <115 mm or weight-for-height z-score <-3 or grade 1-2 bilateral edema who will be clinically well and alert with good appetite);
- Parental consent for the child to participate.
- Healthy children without any chronic or acute illness
Key exclusion criteria (2 listed)
- Presence of any complications of severe malnutrition (severe dehydration, severe anemia, severe pitting edema, anorexia, hypothermia, high pyrexia, acute lower respiratory infection, or hypoglycemia) or immunocompromised.
- Children on antibiotic treatment for any disease in the last 3 months will be excluded.
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 |
|---|---|---|
| Prebiotic galacto-oligosaccharide (GOS) PowderPrebiotic GOS Powder is a galacto-oligosaccharide ingredient low in mono-sugars. Scientific studies have shown positive effects of oligosaccharides, among which galacto-oligosaccharides, on growth of bifidobacterial, stool consistency bowel function and transit time, support of natural defenses and mineral absorption. The product mainly consists of 97% dry matter with 69% prebiotic GOS, 23% lactose and 5% glucose and galactose as monosaccharides. These prebiotics have β-(4) glycosidic linkages and have been proven as safe product | Dietary supplement | Malnutrition (RUTF + prebiotics) |
| Starch OnlyThe Starch Solution is a low-fat diet. | Dietary supplement | Healthy/Control (Starch) |
| RUTF + Starchready-to-use therapeutic food and The Starch Solution is a low-fat diet. | Dietary supplement | Malnutrition (RUTF + Starch) |
Primary outcome
Microbiome diversity
Time frame: 8 Weeks
Microbiome diversity examination among malnourished children using 16 Svedberg (S) ribosomal ribonucleic acid gene sequencing. The microbiome diversity index measures the diversity of microbial species in malnourished children's gut microbiota, comparing it to reference or control populations. Higher values indicate greater diversity, providing insights into malnutrition's impact on gut microbiota composition.
3 secondary outcomes
Anthropometric Measurements
Time frame: 8 Weeks
Neurodevelopment Assessment
Time frame: 8 Weeks
Muscle mass accumulation
Time frame: 8 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Derived from this study: PubMed 39593072Saleem J, Zakar R, Iqbal S, Arshad M, Shahzad R, Batool M, Nawaz M, Butt MS, Fischer F. Effects of prebiotics on microbial diversity and abundance in young children with acute malnutrition: study protocol for a multi-centered, double-blinded randomized controlled trial. Trials. 2024 Nov 26;25(1):798. doi: 10.1186/s13063-024-08647-z.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic galacto-oligosaccharide (GOS) Powder, Starch Only and RUTF + Starch in people with Child Malnutrition, run by University of the Punjab at 1 site in Pakistan.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Dec 2023. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javeria Saleem, PhD (+923004366011, js.iscs@pu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome diversity (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06155474, which also lists 1 linked publication.
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 4 Dec 2023.