MalnutritionPhase 1/2NCT01841099
Mesalamine in Environmental Enteropathy
A Phase 1/2 study testing Mesalamine in people with Malnutrition, run by Kelsey Jones at 1 site in Kenya.
Trial summary
Undernutrition is one of the most important health issues in Kenya. Children who are chronically undernourished do not reach their full potential and are at increased risk of infectious disease. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- Mesalamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteKenya
- Study dates
- Jun 2013to May 2014
- Phase
- Phase 1/2
- 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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 1 to 5 years old.
- Provision of informed consent by parent or guardian.
- Stunting (height for age z score <-2)
- Severe malnutrition (one or more of mid-upper arm circumference <11.5cm, weight for height z score <-3, or nutritional oedema).
- Eligible for outpatient management of malnutrition (i.e. no evidence of acute infection, and passes 'appetite test' according to national guidelines).
- Evidence of chronic inflammation (elevated erythrocyte sedimentation rate, ESR >20mm/hr).
Who cannot join
- Known HIV disease or tuberculosis.
- Known previous renal disease or asthma.
- Known allergy or hypersensitivity to mesalamine, other salicylate drugs, or any of the product ingredients.
- Biochemical evidence of acute renal or hepatic impairment on screening blood tests.
- Thrombocytopenia
- Recent (previous two weeks) bloody diarrhoea.
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- Concurrent medication known to interact with the study drug (non-steroidal anti-inflammatory drugs, ranitidine, proton-pump inhibitors)
- Acute infection requiring treatment, e.g. lower respiratory tract infection or febrile illness.
- Other reason at the discretion of the attending clinician (independent of the trial team).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Placebo-controlled Trial of a Gut Immunomodulatory Agent (Mesalamine) to Tackle Environmental Enteropathy in Acutely Malnourished Children: A Pilot Study.
Undernutrition is one of the most important health issues in Kenya. Children who are chronically undernourished do not reach their full potential and are at increased risk of infectious disease. Stunting occurs in a third of Kenyan children and has severe and long-term consequences in terms of health, development, and poverty. Several studies have shown that stunting is frequently associated with subclinical inflammation of the bowel, a condition referred to as Environmental Enteropathy (EE), previously known as 'tropical sprue' or 'tropical enteropathy'. EE is clinically similar to childhood inflammatory bowel diseases (IBD), including Crohn's disease. The treatment of IBD routinely involves provision of gut immunomodulatory agents, but this approach has never been tried in EE.
This proposal outlines a pilot double-blind randomised placebo-controlled trial of mesalamine (also called mesalazine - the safest immunomodulator used in IBD with least systemic activity) in treatment of severely malnourished children with EE.
- Conditions
- Malnutrition
- Being tested
- Mesalamine, Placebo granules
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesalamineDrug
Also called Mesalazine, Pentasa (trade name)
Mesalamine granules
Placebo granulesDrug
Provided by Ferring Pharma
| Study group | Role | What they receive |
|---|---|---|
| Mesalamine | Experimental | Mesalamine. Mesalamine granules. 30 mg/kg/day oral for 7 days followed by 50 mg/kg/day oral for 21 days if tolerated. Receives: Drug: Mesalamine |
| Placebo granules | Placebo comparator | Placebo granules Receives: Drug: Placebo granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events/serious adverse events
This trial represents the first time a member of a class of drugs are to be used in a particular vulnerable group patient group. It's primary purpose is to conduct an early evaluation of safety and acceptability in this and the study is not powered to address any specific outcomes. It represents a modified Phase IIa design
Measured: Day 0 to day 28 and day 0 to day 56
Compliance with treatment
This trial represents the first time a member of a class of drugs are to be used in a particular vulnerable group patient group. It's primary purpose is to conduct an early evaluation of safety and acceptability in this and the study is not powered to address any specific outcomes. It represents a modified Phase IIa design
Measured: Day 0 to day 28
Secondary outcomes (9)
Changes in height
mm/day
Measured: Day 0 to 28 and day 0 to day 56
Changes in levels of anti-Endotoxin Core IgG (EndoCAb)
Measured: Day 0 - Day 28 and Day 0 - Day 56
Changes in fecal calprotectin levels
Measured: Day 0 - Day 28 and Day 0 - Day 56
Changes in plasma soluble-CD14
Measured: Day 0 - Day 28 and Day 0 - Day 56
Changes in plasma beta-2 microglobulin
Measured: Day 0 - Day 28 and Day 0 - Day 56
Changes in plasma neopterin
Measured: Day 0 - Day 28 and Day 0 - Day 56
Changes in weight
g/kg/day
Measured: Day 0 - Day 28 and Day 0 - Day 56
Changes in mid-upper arm circumference
mm/day
Measured: Day 0 - Day 28 and Day 0 - Day 56
Changes in C-Reactive Protein
Measured: Day 0 - Day 28, and Day 0 - Day56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2014
- Study completionMay 2014
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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kelsey Jones
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Sponsor-investigator, Kelsey Jones, KEMRI-Wellcome Trust Collaborative Research Program
- Investigators
- Kelsey DJ Jones, MBBS BA MRCPCH, Principal investigator, KEMRI-Wellcome Trust Research Programme and Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841099
- Sponsor's protocol ID
- KEMRI_CT_2013/0016
- Other IDs
- SSC 2223
- Status last verified
- Jul 2014
- First submitted
- 15 Apr 2013
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jones KD, Hunten-Kirsch B, Laving AM, Munyi CW, Ngari M, Mikusa J, Mulongo MM, Odera D, Nassir HS, Timbwa M, Owino M, Fegan G, Murch SH, Sullivan PB, Warner JO, Berkley JA. Mesalazine in the initial management of severely acutely malnourished children with environmental enteric dysfunction: a pilot randomized controlled trial. BMC Med. 2014 Aug 14;12:133. doi: 10.1186/s12916-014-0133-2.
PubMed 25189855
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Placebo-controlled Trial of a Gut Immunomodulatory Agent (Mesalamine) to Tackle Environmental Enteropathy in Acutely Malnourished Children: A Pilot Study.
- ClinicalTrials.gov ID
- NCT01841099
- Acronym / sponsor ID
- KEMRI_CT_2013/0016
- Conditions
- Malnutrition
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Kelsey JonesUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- Jun 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 Apr 2013 (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.
Undernutrition is one of the most important health issues in Kenya. Children who are chronically undernourished do not reach their full potential and are at increased risk of infectious disease. Stunting occurs in a third of Kenyan children and has severe and long-term consequences in terms of health, development, and poverty. Several studies have shown that stunting is frequently associated with subclinical inflammation of the bowel, a condition referred to as Environmental Enteropathy (EE), previously known as 'tropical sprue' or 'tropical enteropathy'. EE is clinically similar to childhood inflammatory bowel diseases (IBD), including Crohn's disease. The treatment of IBD routinely involves provision of gut immunomodulatory agents, but this approach has never been tried in EE.
This proposal outlines a pilot double-blind randomised placebo-controlled trial of mesalamine (also called mesalazine - the safest immunomodulator used in IBD with least systemic activity) in treatment of severely malnourished children with EE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesalamine | Experimental | Drug: MesalamineMesalamine. Mesalamine granules. 30 mg/kg/day oral for 7 days followed by 50 mg/kg/day oral for 21 days if tolerated. |
| Placebo granules | Placebo comparator | Drug: Placebo granulesPlacebo granules |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 1 to 5 years old.
- Provision of informed consent by parent or guardian.
- Stunting (height for age z score <-2)
- Severe malnutrition (one or more of mid-upper arm circumference <11.5cm, weight for height z score <-3, or nutritional oedema).
- Eligible for outpatient management of malnutrition (i.e. no evidence of acute infection, and passes 'appetite test' according to national guidelines).
Key exclusion criteria (9 listed)
- Known HIV disease or tuberculosis.
- Known previous renal disease or asthma.
- Known allergy or hypersensitivity to mesalamine, other salicylate drugs, or any of the product ingredients.
- Biochemical evidence of acute renal or hepatic impairment on screening blood tests.
- Thrombocytopenia
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 |
|---|---|---|
| MesalamineAlso: Mesalazine, Pentasa (trade name)Mesalamine granules | Drug | Mesalamine |
| Placebo granulesProvided by Ferring Pharma | Drug | Placebo granules |
Primary outcome
Frequency of adverse events/serious adverse events
Time frame: Day 0 to day 28 and day 0 to day 56
This trial represents the first time a member of a class of drugs are to be used in a particular vulnerable group patient group. It's primary purpose is to conduct an early evaluation of safety and acceptability in this and the study is not powered to address any specific outcomes. It represents a modified Phase IIa design
Compliance with treatment
Time frame: Day 0 to day 28
This trial represents the first time a member of a class of drugs are to be used in a particular vulnerable group patient group. It's primary purpose is to conduct an early evaluation of safety and acceptability in this and the study is not powered to address any specific outcomes. It represents a modified Phase IIa design
9 secondary outcomes
Changes in height
Time frame: Day 0 to 28 and day 0 to day 56
Changes in levels of anti-Endotoxin Core IgG (EndoCAb)
Time frame: Day 0 - Day 28 and Day 0 - Day 56
Changes in fecal calprotectin levels
Time frame: Day 0 - Day 28 and Day 0 - Day 56
Changes in plasma soluble-CD14
Time frame: Day 0 - Day 28 and Day 0 - Day 56
Changes in plasma beta-2 microglobulin
Time frame: Day 0 - Day 28 and Day 0 - Day 56
Changes in plasma neopterin
Time frame: Day 0 - Day 28 and Day 0 - Day 56
Changes in weight
Time frame: Day 0 - Day 28 and Day 0 - Day 56
Changes in mid-upper arm circumference
Time frame: Day 0 - Day 28 and Day 0 - Day 56
Changes in C-Reactive Protein
Time frame: Day 0 - Day 28, and Day 0 - Day56
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 Jul 2014.
- Derived from this study: PubMed 25189855Jones KD, Hunten-Kirsch B, Laving AM, Munyi CW, Ngari M, Mikusa J, Mulongo MM, Odera D, Nassir HS, Timbwa M, Owino M, Fegan G, Murch SH, Sullivan PB, Warner JO, Berkley JA. Mesalazine in the initial management of severely acutely malnourished children with environmental enteric dysfunction: a pilot randomized controlled trial. BMC Med. 2014 Aug 14;12:133. doi: 10.1186/s12916-014-0133-2.
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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.
Kelsey DJ Jones, MBBS BA MRCPCH principal investigator
KEMRI-Wellcome Trust Research Programme and Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mesalamine in people with Malnutrition, run by Kelsey Jones at 1 site in Kenya.
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 9 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 Jul 2014. 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 Kenya. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Frequency of adverse events/serious adverse events (time frame: Day 0 to day 28 and day 0 to day 56). 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?
On the ClinicalTrials.gov record for NCT01841099, 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 11 Jul 2014.