Pill-Sized camera could unlock secrets of childhood malnutrition
NCT ID NCT04275167
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether a special camera capsule, swallowed like a pill, can safely take pictures of the small intestine in children with environmental enteric dysfunction (EED), a gut condition linked to malnutrition. Researchers will also use a thin tube camera through the nose in some adults. The goal is to see if these devices are comfortable and work well, not to treat the disease. About 170 people in Pakistan will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to better ways to diagnose and understand EED, a gut condition that causes malnutrition in children.
- What could go wrong
- This is a small early-stage feasibility study, not a treatment trial. The device may not work well in all participants, and results may not apply to other populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 170 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2017
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 months to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
The Inclusion Criteria: * Children must be 6 months to 59 months old * Adult participants 18 years of age or older scheduled for a standard of care endoscopy * EED manifesting as malnourishment (WHZ\<-2) without clear etiology or healthy subjects with WHZ \>=0 * Participants and/or parents/guardians must be able to give informed consent/assent * Participants and/or parents/guardians must be willing to provide consent for live streaming of the procedure * Participants must be able to follow fasting instructions prior to the procedure Inclusion criteria for Pregnant women: * Participants 18 years and older * Participants who are in their 2nd trimester of singleton pregnancy as confirmed by an ultrasound * Participants with a BMI below 18.5 without clear etiology and healthy pregnant women with BMI between 18.5 -24.5. * Participants must be able to follow fasting instructions prior to the procedure * Participants must be able to consent to the procedure Tethered Capsule Exclusion Criteria: * Participants with any history of esophageal or intestinal strictures or prior GI surgery * Participants with history of pyloric stenosis * Participants with HIV diagnosis Trans Nasal Exclusion Criteria: * Participants with any contraindications for NG/NJ tube placement, including but not limited to those listed below: * Participants with any history of esophageal or intestinal strictures or prior GI surgery * Participants with history of pyloric stenosis or atresia * Participants with suspected or diagnosed HIV, Hepatitis B and C * Participants with any history of esophageal or intestinal strictures or prior GI surgery * Participants with a history of upper gastrointestinal surgery including fundoplication * Participants with upper GI obstruction * Participants with short bowel syndrome * Participants with upper respiratory infection at least 7 days prior to the procedure * Deviated septum or any other anatomical abnormalities of the nasopharynx or upper gastrointestinal region, history of trans-sphenoidal surgery, facial or cranial trauma and fractures, chronic sinusitis, esophageal strictures, varices etc. * Participants on drugs which impair clotting like anticoagulants and antiplatelet drugs, NSAIDS, history of bleeding disorders. * Participants with upper GI bleeding Microbiome Brush Exclusion Criteria \- Participants with any contraindications to gastrointestinal biopsies as per standard of care For pregnant participants: * Participants with high-risk pregnancy conditions at the discretion of the subject's physician and the PI * Pregnant participants with a history of hyperemesis gravidarum * Pregnant participants with a history of severe anemia * Pregnant participants with gestational thrombocytopenia * Pregnant participants with Type 1 diabetes * Pregnant participants with Type 2 diabetes on medication and gestational diabetes requiring medication
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aga Khan Medical Center
Karachi, Pakistan
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Other studies related to the condition(s) this trial covers.
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- Could a probiotic fix gut problems in pregnancy and prevent stunting?
- Zimbabwe study tracks how Mother's nutrition shapes Baby's gut and future health