Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03564249
Other study ID # 14GA014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2018
Est. completion date June 30, 2019

Study information

Verified date August 2019
Source Nottingham University Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Constipation in children is a common problem. Managing these children is difficult, partly because they do not respond to laxatives and partly because their bowel problem cannot be defined. A "gut transit time" test can add information to help choose the best therapy but this is often not carried out because of the unsuitable radiation dose involved in the current methods such as X-ray. A new Magnetic Resonance Imaging (MRI) method to measure gut transit time using inert mini-capsules, the size of small pine nuts, has recently been developed.

This study is the first feasibility test of the new mini-capsules in paediatric constipation. 25 patients and 25 healthy controls will participate. The study will measure gut transit time using MRI and the mini-capsules before and after the young patients receive standard treatment.


Description:

One in ten children worldwide has constipation and it becomes chronic in 30% of these children, affecting their and their families' well-being. Managing these children is difficult, partly because they do not respond to laxatives and partly because their bowel problem cannot be defined. If the doctors could send the children for a quick test that indicates the time that food takes to travel through the gut (the "gut transit time"), they could use this information to help choose the best therapy, for example to decide if a patient needs surgery. The test could also be used to follow up the effects of different treatments. Gut transit time is often not tested due to the unsuitable radiation dose involved in the current methods such as X-ray. Doctors' decisions have to rely mostly on symptoms, leading to repeated appointments, frustration and a waste of NHS money.

A new method to measure gut transit time using mini-capsules, the size of small pine nuts, has recently been developed. The mini-capsules are swallowed but do not dissolve and their journey through the gut is imaged using Magnetic Resonance Imaging (MRI). From the images doctors can determine the gut transit time. MRI is harmless and can be used repeatedly to follow up the response to treatment.

This study will test these new mini-capsules to determine their suitability for paediatric use. Areas of interest are ease of imaging in the gut using MRI and whether they are small enough such that their emptying from the stomach and transit through the gut are similar to food. The study will test the mini-capsules in children with constipation, to measure gut transit time before and after they receive their usual treatment from their doctors. This will assess if the mini-capsules can detect changes in treatment and will make them clinically useful.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 18 Years
Eligibility Inclusion Criteria:

- Aged 7 - 18 years old

- Male or female

- Able to give assent or have a parent able to give informed consent

- Willing to allow their GP or consultant, if appropriate, to be notified of participation in the clinical investigation

- Presenting with intractable constipation at secondary or tertiary care and considered for possible treatment which may include new drugs or procedures (Group1 only)

- Healthy bowel habit and does not suffer from constipation or diarrhoea (Group 2 only)

Exclusion Criteria:

- Female participants who are pregnant, lactating or planning pregnancy during the course of the investigation.

- Any history of gastrointestinal surgery such as colectomy or small bowel resection.

- Existing ACE procedure before the first MRI scan (Group 1 only)

- Significant renal or hepatic impairment

- Contraindications for MRI scanning such as metallic implants and penetrating eye injury.

- Inability to lie flat and relatively still for less than 5 minutes

- Poor understanding of English language

- Any other significant disease or disorder (other than intractable constipation for Group 1)

- Participation in another research clinical investigation involving an investigational product in the past 12 weeks.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
MiniCap
The MiniCap device consists of small, completely inert mini-capsules that, once ingested, can be imaged inside the gastrointestinal tract using MRI, thereby creating a new MRI alternative to the radiopaque marker X-ray test to measure gut transit. The MRI mini- capsules are visualised in the gut using a single fat, water, in-phase and out-of-phase scan

Locations

Country Name City State
United Kingdom Nottingham Digestive Diseases Centre Nottingham Nottinghamshire

Sponsors (2)

Lead Sponsor Collaborator
Nottingham University Hospitals NHS Trust University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Whole gut transit time (hours) Whole gut transit time measured from the number of MiniCap retained in the bowel as detected by MRI imaging 1 week time frame
Secondary EQ-5D-Y questionnaires The EuroQOL five dimensions questionnaire for young (EQ-5D-Y) is the EuroQuol descriptive system for children and adolescents. It describes 5 dimensions of Quality of Life: mobility, looking after myself, doing usual activities, having pain or discomfort and feeling worried, sad or unhappy. Each dimension has 3 levels: no problems, some problems and a lot of problems. The younger patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the younger patient's health state. An EQ-5D health state is the set of responses to the 5 dimensions of EQ-5D, as completed by a patient or respondent. For instance, a fairly healthy person may have an EQ-5D health state of 1-2-1-1-1. The higher the digits the worse the health state. Recorded at 2 time points before and after intervention (one week time frame)
Secondary EQ-VAS The EuroQOL visual analogue scale (EQ-VAS) records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The scale is numbered from 1 to 100 with 100 being the best health and 0 the worst health. Measured at 10 time points before and after intervention (one week time frame)
Secondary AC-QoL questionnaire (total score) The Adult carers quality of life (AC-QoL questionnaire) is a questionnaire for use with adult carers that measures quality of life in eight separate domains: support for caring; caring choice; caring stress; money matters; personal growth; sense of value; ability to care; and carer satisfaction. The questions are designed for scoring between 0 to 3 (from never to always). The composite score reflects the overall quality of life with low scores 0-40 representing a low reported quality of life and greater than 81 a high reported quality of life. Measured at 2 time points before and after intervention (one week time frame)
Secondary Change in whole gut transit time (hours) Change in whole gut transit time measured from the number of MiniCap retained in the bowel as detected by MRI imaging before and after standard treatment for constipation Measured at 2 time points before and after standard treatment for constipation (approximately 6 months time frame)
Secondary Number of participants completing the study The number of participants completing the entire study will be used to assess feasibility Measured at 1 time point after starting the intervention (one week time frame)
Secondary Number of adverse events The number of adverse events will be used to assess safety Measured at 1 time point after starting the intervention (one week time frame)
See also
  Status Clinical Trial Phase
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Recruiting NCT06292949 - Clinical Study of Resistant Starch in Improving Constipation N/A
Recruiting NCT04132661 - MRI Assessment of Mode of Action of Bisacodyl, Single Dose Phase 4
Completed NCT02726295 - The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study Phase 4
Terminated NCT02839889 - Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation) Phase 4
Recruiting NCT02255747 - Anal Dilatation for Infants and Children With Constipation N/A
Completed NCT02246647 - Biomarkers for Intestinal Permeability in Patients With Constipation
Completed NCT01566409 - Maintenance Treatment for Children With Constipation N/A
Completed NCT02863848 - Effect of Inulin-type Fructans on Constipated Children. N/A
Completed NCT01695915 - Diurnal Variation in Rectal Diameter N/A
Completed NCT01710579 - Normal Values in Ano-rectal 3D High Resolution Manometry N/A
Completed NCT02658201 - Ultrafast MRI Imaging to Exclude Constipation N/A
Completed NCT01411501 - Efficacy and Safety of Acupuncture for Functional Constipation Phase 3
Completed NCT01438567 - A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy Phase 3
Completed NCT01474499 - A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation Phase 3
Completed NCT01170039 - The Effectiveness of Lubiprostone in Constipated Diabetics Phase 4
Completed NCT00931853 - Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC). Phase 3
Active, not recruiting NCT02442115 - Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
Terminated NCT01003249 - Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen Phase 4
Completed NCT00994851 - Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment. Phase 3