Whole gut transit time measurement using MRI in constipation

ISRCTN	ISRCTN17411836
DOI	https://doi.org/10.1186/ISRCTN17411836
Integrated Research Application System (IRAS)	342112
Central Portfolio Management System (CPMS)	61823
National Institute for Health and Care Research (NIHR)	207480
Protocol serial number	23GDI013
Sponsor	Nottingham University Hospitals NHS Trust
Funder	National Institute for Health and Care Research

Submission date: 17/11/2025
Registration date: 11/12/2025
Last edited: 11/12/2025

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Patients with constipation may have an impaired gastrointestinal transit time, i.e. the time it takes for food to travel through their intestines; having this information may help doctors to choose treatment. The current method to measure this gastrointestinal transit time uses X-rays, which use harmful radiation and do not provide good-quality images of the bowel.

Who can participate?
Patients aged 7 years and above who have been diagnosed with chronic constipation are eligible to participate in this study.

What does the study involve?
The research team have invented a new method to measure gastrointestinal transit time. The new method uses small TransiCap MRI visible capsules. They are easy to swallow but do not dissolve in the body and do not release any substance. The TransiCap capsules contain a liquid (of oil and water) that shows up brightly when imaged using Magnetic Resonance Imaging or MRI. MRI is a common and safe medical imaging technique to locate the TransiCap capsules inside the intestines of the patients and see how fast or slow they travelled.

Taking part in the study will involve attending 3 study visits. The first visit, called the baseline visit, will take place either at the hospital or remotely via a telephone/video call, at the discretion of the local hospital. The next two visits are for MRI scans and will take place at the local MRI unit. The study will involve the participant swallowing 20 mini-capsules a day on Day 1, Day 2 and Day 3 (60 capsules in total over the three days), followed by two MRI scans, one at Day 5 and one at Day 28. The capsules can be swallowed with liquids, smoothies or yoghurts to make swallowing easier. The study will also collect information through questionnaires.

What are the possible benefits and risks of participating?
We cannot guarantee any treatment benefits for the participants; however, their involvement in the study will help to make this new test available in the future for people with similar conditions.

There is a small risk of choking or aspirating (when food enters the airways or lungs) when anything is taken orally, like food. This risk is the same as swallowing the capsules. To minimise this risk, we will exclude participants if they have issues with swallowing. In the unlikely event that aspiration does happen, the TransiCap capsules are expected to stay intact and could be removed in hospital with a bronchoscope under anaesthetic. The capsules are made of a material that is medically safe and sterile, can be easily swallowed, will not burst or break down in the body, but pass out with the stools after a few days. The filling of the capsules is not expected to interact with the body; it only helps us to see the capsules as they travel along the intestines.

Where is the study run from?
This is a multicentre study and will be running simultaneously in Nottingham University Hospital, University College London Hospital and the Greater Ormond Street Hospital for children.

When is the study starting and how long is it expected to run for?
May 2026 to September 2027

Who is funding the study?
The National Institute for Health and Care Research (NIHR), i4i grant, UK.

Who is the main contact?
Dr. Luca Marciani, luca.marciani@nottingham.ac.uk

Contact information

Prof Luca Marciani
Principal investigator

Translational Medical Sciences, School of Medicine, University of Nottingham
Nottingham
NG7 2UH
United Kingdom

ORCID ID	0000-0001-9092-4300
Phone	+44 01158231248
Email	luca.marciani@nottingham.ac.uk

Dr Soham Mukherjee
Public, Scientific

Translational Medical Sciences, School of Medicine, University of Nottingham
Nottingham
NG7 2UH
United Kingdom

ORCID ID	0009-0005-4116-5017
Phone	+44 7585984322
Email	soham.mukherjee@nottingham.ac.uk

Study information

Primary study design	Interventional
Allocation	N/A: single arm study
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Single
Purpose	Device feasibility
Scientific title	A multicentre clinical investigation to assess safety and performance of TransiCap, swallowable MRI-visible capsules for monitoring gut transit time in constipation
Study acronym	MAGIC3
Study objectives	The primary objective of this study is to test the performance of the TransiCap device as a method for obtaining whole gut transit time in patients 7 years of age and above with chronic constipation, and to assess the safety of the TransiCap device in doing so.
Ethics approval(s)	Not yet submitted
Health condition(s) or problem(s) studied	Performance of the TransiCap device as a method for obtaining whole gut transit time in Patients (Age-7 years old and above) with Chronic Constipation.
Intervention	This study is a Pre-market, Pivotal confirmatory clinical investigation of a medical device. Single arm, unblinded, multi-centre, case series. The research team have invented a new method to measure gastrointestinal transit time. The new method uses TransiCap MRI visible capsules, which are very small. They are easy to swallow but do not dissolve in the body and do not release any substance. Taking part in the study will involve attending 3 study visits. The first visit, called the baseline visit, will take place either at the hospital or remotely via a telephone/video call, at the discretion of the local hospital. The next two visits are for MRI scans and will take place at the local MRI unit. The study will involve the participant swallowing 20 mini-capsules a day on Day 1, Day 2 and Day 3 (60 capsules in total over the three days), followed by two MRI scans, one at Day 5 and one at Day 28. The capsules can be swallowed with liquids, smoothies or yoghurts to make swallowing easier. The study will also collect information on bowel habits, symptoms and quality of life through questionnaires during the study.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	TransiCap
Primary outcome measure(s)	Whole gut transit time measured using TransiCap MRI visible capsules and MRI scanning at baseline, days 5 and 28
Key secondary outcome measure(s)	Number of Serious Adverse Events measured using data collected from electronic Case Report Forms (eCRF) at days 5 and 28 Patient acceptability of swallowing the TransiCap MRI visible capsules (usability and acceptability performance) measured using questionnaires at days 1, 2 and 3 Non-inferiority, sensitivity and specificity of the TransiCap test in measuring WGTT and in diagnosing slow transit constipation as compared to reference standard (recorded in the clinical notes and performed within 6 months of this study) measured using analysed MRI images at day 5 Identification of any undesirable side effects (Adverse Device Effects) measured using data collected from eCRF at Days 5 and 28 Number of TransiCap MRI visible capsules swallowed measured using MRI images at days 1, 2 and 3 Visibility of capsules measured using MRI scans at day 5 Number of people completing the MRI study measured using data collected from the eCRF at day 28 Number of patients withdrawn and reason for withdrawal measured using data collected from the eCRF at at time of withdrawal Health-related quality of life measured using the EQ-5D-Y (for children and adolescents) or EQ-5D-5L (adults) at visit 1 and day 6 Self-rated overall health measured using the EuroQol Visual Analogue Scale (EQ VAS) score, AC-QoL score (parents/carers quality of life) at visit 1, days 0, 1, 2, 3, 4, 5 and 6 Constipation measured using the Patient Assessment of Constipation‐Symptoms (PAC-SYM) questionnaire at day 0 Patient symptoms (flatulence, bloating and abdominal pain) measured using a questionnaire at days 0, 1, 2, 3, 4, 5 and 6 Stool form measured using the Bristol stool form chart at days 0, 1, 2, 3, 4, 5 and 6 Demographics including age, sex, height, weight, ethnicity, socioeconomic status measured using data collected in study records at at visit 1 Health economic outcome measured using Clinical Service Receipt Inventory data at day 0
Completion date	30/11/2027

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	7 Years
Upper age limit	99 Years
Sex	All
Target sample size at registration	75
Key inclusion criteria	1. Male or female patients aged 7 years old and above 2. Having a clinical diagnosis of CC, defined broadly as characterised by stools that are infrequent and/or difficult to pass in the absence of mucosal/structural abnormalities. 3. Having had a transit study (either X-ray or gamma scintigraphy) organised within 6 months of the TransiCap test and carried out according to the local site standard procedures 4. Willing to consent for participation in the clinical investigation or, if below 16 years of age, willing to give assent for participation in the clinical investigation and have a parent/carer willing to give informed consent for participation in the clinical investigation. 5. Able (in the Investigators opinion) and willing to comply with all clinical investigation requirements. 6. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the clinical investigation.
Key exclusion criteria	1. Female participants who are pregnant, lactating or planning pregnancy during the course of the clinical investigation. This will be self-reported. 2. Any history of gastrointestinal surgery that could affect gastrointestinal function, such as cholecystectomy, colectomy or small bowel resection. 3. Existing antegrade colonic enema (ACE) procedure. 4. Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury. 5. Inability to lie flat and relatively still for less than 5 minutes. 6. Poor ability to understand instructions or the consent process 7. Difficulties in swallowing tablets, dysphagia or a diagnosis of oesophageal dysmotility 8. The following disease or disorder: an active eating disorder (e.g. anorexia), known presence of bowel strictures, inflammatory bowel diseases, Hirschsprung disease, congenital anorectal malformations, Chronic Intestinal pseudo-obstruction. 9. Unable or unwilling to temporarily discontinue for the duration of the study drugs influencing gut function such as: laxatives, anticholinergics, prokinetics, opioid analgesics (tramadol, morphine, fentanyl, oxycodone, co-codamol and codydramol); antispasmodic Buscopan (hyoscine butylbromide, also known as scopolamine butylbromide 10. Participation in another research clinical investigation involving an investigational product in the past 12 weeks
Date of first enrolment	01/05/2026
Date of final enrolment	30/09/2027

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus

Nottingham University Hospital
Derby Road
Nottingham
NG7 2UH
England

Great Ormond Street Hospital for Children

Great Ormond Street
London
WC1N 3JH
England

University College London Hospitals NHS Foundation Trust

250 Euston Road
London
NW1 2PG
England

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a publicly available repository, in keeping with the funder NIHR position on the sharing of research data. (Repository address to be confirmed)

Editorial Notes

17/11/2025: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).