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CTRI Number  CTRI/2020/04/024512 [Registered on: 08/04/2020] Trial Registered Prospectively
Last Modified On: 04/04/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Descriptive Analytical 
Study Design  Other 
Public Title of Study   To compare availability of milk to the body between adults with and without gut infection 
Scientific Title of Study   Comparison of goat milk protein digestibility in adults with and without environmental enteric dysfunction  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nirupama Shivakumar  
Designation  Post graduate 
Affiliation  St. Johns National Academy of Health Sciences  
Address  Department of Physiology, St. John’s Medical College, Sarjapur Road, Koramangla, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone    
Fax    
Email  nirupama.s@sjri.res.in  
 
Details of Contact Person
Scientific Query
 
Name  Nirupama Shivakumar  
Designation  Post graduate 
Affiliation  st. Johns National Academy of Health Sciences  
Address  Department of Physiology, St. John’s Medical College, Sarjapur Road, Koramangla, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone    
Fax    
Email  nirupama.s@sjri.res.in  
 
Details of Contact Person
Public Query
 
Name  Nirupama Shivakumar  
Designation  Post graduate 
Affiliation  St. Johns National Academy of Health Sciences . Johns National Academy of Health Sciences  
Address  Department of Physiology, St. John’s Medical College, Sarjapur Road, Koramangla, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone    
Fax    
Email  nirupama.s@sjri.res.in  
 
Source of Monetary or Material Support  
DBT India Alliance/ The Wellcome Trust Plot no. 19, #8-2-684/3/K/19, 1st floor, Kaushik Society, road number 12, Banjara Hills, Hyderabad - 500034, T.S., India 
 
Primary Sponsor  
Name  Wellcome Trust DBT India Alliance  
Address  DBT India Alliance/ The Wellcome Trust Plot no. 19, #8-2-684/3/K/19, 1st floor, Kaushik Society, road number 12, Banjara Hills, Hyderabad - 500034, T.S., India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nirupama Shivakumar  St. Johns Medical College and Research Institute   Department of Physiology, Division of Nutrition, 3rd floor, Clinical Research Centre, Robert Koch Bhavan, Sarjapur Road Bangalore 560034
Bangalore
KARNATAKA 
9900070008

nirupama.s@sjri.res.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St. Johns Medical College and Hospital Institutional Ethical Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Apparently healthy adult volunteers  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Normal BMI between18.5 to 25 kg/m²; or either normal or low BMI (<18 kg/m2) for the group with EED 
 
ExclusionCriteria 
Details  1. History of smoking or taking other leisure drugs
2. Consumption of alcohol in the previous 24 hours
3. History of antibiotic usage 4 weeks prior to the study
4. On iron supplementation therapy (3 months)
5. On medication such as NSAID’s, proton pump inhibitors or H2 blockers 2 days prior to and on the study day
6. Participation in any nutritional study in the last 6 months
7. History of food allergy, specifically to milk
8. Diagnosed with chronic medical or surgical illness
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The main aim of this study is to compare the protein digestion and amino acid absorption in adults with and without EED.   Digestibility calculation will be performed from 4 time points starting from the 5th hour to 8th hour and will be compared between the adult EED and without EED group 
 
Secondary Outcome  
Outcome  TimePoints 
To compare true ileal indispensable amino acid digestibility of goat milk and allo-isoleucine absorption between adults with and without EED
To compare the digestibility and absorption indices obtained for adults with and without EED to plasma/fecal intestinal inflammatory biomarkers and fecal elastase-1
 
For the absorption study 4 time points of plasma enrichment of alloisoleucine will be used to calculate the absorption index
For the inflammatory biomarkers and fecal elastase-1, 1 time point stool sample will be taken and compared between the groups 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   No publication at present 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Undernutrition persists as a major public health issue that affects 462 million people world-wide with 165 million children being stunted and 52 million wasted. Both acute (wasting) and chronic malnutrition (stunting) are associated with significant health and economic burdens in low and middle-income countries (LMICs). With consistent failure or low effect sizes observed in nutrient supplementation interventions to alleviate under nutritional status, the impact of a poor environment on growth gained importance. A condition termed environmental enteric dysfunction (EED) was identified, akin to tropical enteropathy, with features of gut dysfunction such as villous atrophy, disruption of the normal gut microbiota, altered gut barrier function, increased local and systemic inflammation, and bacterial translocation, leading to increased intestinal permeability. As a consequence of the gut abnormality noted, there is potential for reduced nutrient digestion and absorption that could lead to low availability of nutrients to meet the body’s demands, which in turn influences the functionality of the individual. However, there are no studies in humans demonstrating this reduced digestive and absorptive capacity for nutrients particularly in an EED context. There is a lack of consensus on reliable diagnostic tests available for EED, in spite of multiple biomarkers that have been proposed and studied that relate to the various domains of EED. The dual sugar absorption test (lactulose with mannitol or rhamnose) is widely accepted for the assessment of intestinal permeability, albeit its associated limitations. Therefore, this study aims to first, identify adults with EED using the dual sugar absorption test, second, to determine the absorptive and digestive capacity of amino acids in these individuals. The absorptive capacity will be assessed by adopting an inert stable amino acid isotope (allo-isoleucine), and the digestion will be measured using the recently development dual stable isotope tracer technique. The intrinsically 2H labeled goat milk will be used in the digestion protocol. In addition to this, other intestinal inflammatory markers in the plasma and feces (plasma kynurenine tryptophan ratio [KTR] and fecal neopterin, myeloperoxidase [MPO], alpha-1 antitrypsin [AAT]) and pancreatic exocrine function (13C-Mixed triglyceride [MTG], Fecal Elastase-1[FE-1]) will be assessed and correlated with digestion/absorption in the same set of adults, in order to advance understanding of the interlinked mechanistic pathways proposed in EED. The study is proposed in adults rather than children, as it is invasive in nature where the labeled amino acid will be intravenously infused.

 
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