Introduction of a community-based intervention for children with chronic constipation

ISRCTN	ISRCTN07833068
DOI	https://doi.org/10.1186/ISRCTN07833068
Protocol serial number	N0045126756
Sponsor	Department of Health
Funder	Birmingham Children's Hospital NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Susan Protheroe
Scientific

Birmingham Children's Hospital
Department of Gastroenterology
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom

Phone	+44 (0)121 333 8720
Email	Sue.protheroe@bch.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Introduction of a community-based intervention for children with chronic constipation
Study objectives	To assess the effect of the introduction of a primary care-based intervention for children with constipation compared to conventional hospital based management.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Digestive System: Constipation
Intervention	A randomised controlled trial to compare a new nurse-led service with conventional hospital-based management for children with constipation.
Intervention type	Other
Primary outcome measure(s)	1. Clinical outcomes: remission and relapse of symptoms 2. Quality of life/patient and parental satisfaction 3. Cost benefits: on-going treatment, nurse contacts, out-patient visits and hospital admission
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/03/2004

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	15 Years
Sex	All
Target sample size at registration	40
Key inclusion criteria	40 children aged 2-15 years with moderate to severe chronic constipation referred to gastroenterologists and general paediatricians in Birmingham Children's Hospital NHS Trust.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/04/2003
Date of final enrolment	31/03/2004

Birmingham Children's Hospital

Birmingham
B4 6NH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

29/04/2016: No publications found, verifying study status with principal investigator