Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202302683128875 Date of Approval: 08/02/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A feasibility study of an intestinal adsorbent in childhood diarrhoea in The Gambia (INTAGAM)
Official scientific title Intestinal adsorbent in childhood diarrhoea in Gambia
Brief summary describing the background and objectives of the trial Episodes of diarrhoea are common and a leading cause of death in young children in The Gambia. The main problem is “dehydration” and the most important treatment for children with no or some dehydration is to give oral rehydration fluid (ORF) and zinc. However, diarrhoea may last for several days despite these treatments. This feasibility study will allow us to see if we can do a larger future study to see whether giving an adsorbent that binds the infections and toxins in the gut that cause diarrhoea shortens the illness. This study will also help us design the larger study. The adsorbent is “Enterosgel®”, a silicon-based product that is licensed as a medical device in several coutries and approved for use in people with diarrhoea of all ages. Several studies have tested Enterosgel® in children and adults with diarrhoea and other problems and it has not caused any important harmful effects. However, it has not been tested in young children in a low resource setting. We plan to recruit 50 children aged 6-59 months attending the Department of Paediatrics, Edward Francis Small Teaching Hospital, Banjul, The Gambia with diarrhoea of 3 or less days duration with either no or some dehydration. We will exclude children with severe dehydration (that require IV fluids), malnutrition or any other significant illness. We will randomise them to either Enterosgel® and ORF or ORF alone (standard treatment). All children will be managed according to WHO guidelines including treatment with zinc. The study has an initial blinded phase (0-4 hours; in hospital) and an open phase (1-5 days likely at home with symptom diary and daily mobile phone follow-up; we will provide mobile phone credit). The main outcomes are the acceptability of the Enterosgel®, hydration status at 4 hours, duration of the diarrhoea and vomiting. We will also measure electrolytes and markers of infection in blood at baseline and 4 hours and test stools to identify common causes of diarrhoea.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) INTAGAM
Disease(s) or condition(s) being studied Digestive System,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Acute infectious diarrhoea
Purpose of the trial Treatment: Devices
Anticipated trial start date 02/04/2023
Actual trial start date 25/08/2023
Anticipated date of last follow up 29/02/2024
Actual Last follow-up date 31/05/2024
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard treatment oral rehydration fluid and oral zinc Volume of oral rehydration fluid and dose of oral zinc according to WHO guidelines. For zinc: • <6 months: ½ tab (10mg) daily for 14 days • 6 months or older: 1 tab (20mg) daily for 14 days Oral rehydration fluid for the duration of the diarrhoea illness. Oral zinc for 10-14 days. Standard management of acute infectious diarrhoea with no or some dehydration according to WHO guidelines. 25 Active-Treatment of Control Group
Experimental Group Enterosgel Children under 1 year: 2.5g (using 2.5g measuring spoon) 3 times a day Children 1–6 years: 5g (using 5g measuring spoon) 3 times a day On the first day of treatment, the first dose of Enterosgel® will be doubled and 8 doses administered according to treatment guideline. Up to 5 days Medical device: intestinal adsorbent consisting of polymethylsiloxane based hydrogel. Formulated as a gel in a tube or packet that is easily suspended in water. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Children aged 6 to 59 months with acute diarrhoea (3 or more loose or watery stools in 24 hours) for less than 4 days duration (to exclude episodes that are already resolving) and either no or some dehydration defined according to WHO Integrated Management of Childhood Illness criteria • Written parent/guardian informed consent • Diarrhoea lasting 4 or more days • Severe dehydration according to WHO Integrated Management of Childhood Illness criteria • Severe acute malnutrition defined as mid-upper arm circumference <11.5cms, weight-for-length/height z score <-3 and/or nutritional oedema (bilateral pedal oedema ascribed by the clinician to result from malnutrition). • A suspected or confirmed significant concomitant illness such as malaria, sepsis or dysentery with systemic disturbance (e.g. toxicity; signs of peritonism) • Suspected intestinal obstruction • Use of anti-diarrhoeal medications, probiotic supplements or other intestinal adsorbents (e.g. activated charcoal, kaoline, diosmectite) • Use of modified-release medications • Use of any clinical trial investigational medication within the last 30 days before screening visit • Any underlying condition that in the health professional’s or investigator’s opinion could affect the child’s participation in this study or the results of this study • No access to a mobile phone or land line for follow-up at home Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 59 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/01/2023 Gambia Government MRC Joint Ethics Committee
Ethics Committee Address
Street address City Postal code Country
MRC Unit The Gambia at LSHTM Fajara PO Box 27 Gambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Duration of diarrhoea defined as time (hours) from randomisation to last watery stool (takes the shape of the container) Daily from 1-5 days
Secondary Outcome • Hydration status at 4 hours (end of blinded phase) according to clinical assessment based on WHO IMCI criteria and change in weight from 0 to 4 hours • Volume of ORF / ORF + Enterosgel® taken • Requirement for naso-gastric tube fluids • Evolution to severe disease defined as requirement for intravenous (IV) fluids or hospital admission after starting treatment (e.g. because of persistent vomiting; worsening dehydration) • Duration of diarrhoea defined as time (hours) from randomisation to first non-watery stool (has its own form) • Percentage of patients with diarrhoea that has resolved on days 3 and day 5 • Vomiting • Abdominal pain • Vesikari score calculated for the illness (up to a maximum of 5 days) • Safety including measurement of serum electrolytes in blood samples collected at baseline and 4 hours • Adverse events Daily from 1-5 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Edward Francis Small Teaching Hospital Marina Parade Banjul FC4CWW4 Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Enteromed Ltd 85 Great Portland St London W1W 7LT United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Enteromed Ltd 85 Great Portland St London W1W 7LT United Kingdom Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Stephen Allen stephen.allen@lstmed.ac.uk +2202522752 Marina Parade
City Postal code Country Position/Affiliation
Banjul FC4C WW4 Gambia Consultant Paediatrician
Role Name Email Phone Street address
Public Enquiries Stephen Allen stephen.allen@lstmed.ac.uk +2202522752 Marina Parade
City Postal code Country Position/Affiliation
Banjul FC4C WW4 Gambia Consultant Paediatrician
Role Name Email Phone Street address
Scientific Enquiries Stephen Allen stephen.allen@lstmed.ac.uk +2202522752 Marina Parade
City Postal code Country Position/Affiliation
Banjul FC4C WW4 Gambia Consultant Paediatrician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data will be available on reasonable request to the study PI. Informed Consent Form,Study Protocol After publication of the main study findings in a peer-reviewed journal Please contact the PI for access to fully anonymised IPD. The PI and co-investigators will assess requests and confirm approval by the local ethics commitee before sharing anonymised IPD.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
n/a No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information