An investigation into the effects of diindolylmethane (BioResponse DIM®) supplementation in women with low-grade cervical cytological abnormalities

ISRCTN	ISRCTN47437431
DOI	https://doi.org/10.1186/ISRCTN47437431
ClinicalTrials.gov (NCT)	NCT00462813
Protocol serial number	N/A
Sponsor	Queen Mary and Westfield College, University of London (UK)
Funder	Cancer Research UK (C8162/A4609).

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Prof Peter Sasieni
Scientific

Wolfson Institute
Queen Mary College
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Phone	+44 (0)207 014 0260
Email	peter.sasieni@cancer.org.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	An investigation into the effects of diindolylmethane (BioResponse DIM®) supplementation in women with low-grade cervical cytological abnormalities
Study acronym	CRISP-1
Study objectives	DIM® will prevent progression and accelerate regression of cervical intra-epithelial neoplasia.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cervical neoplasia.
Intervention	Double-blind, placebo-controlled trial. Randomisation is in the ratio 2 DIM®: 1 placebo. Diindolylmethane (BioResponse DIM® - 75 mg capsules) - two capsules daily for 6 months.
Intervention type	Other
Primary outcome measure(s)	Reduction in cervical intra-epithelial neoplasia grade 2 (CIN2) or worse.
Key secondary outcome measure(s)	Cytology, lesion size, human papillomavirus (HPV) status (all at 6 months).
Completion date	31/12/2008

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	3000
Key inclusion criteria	Women with a first mildly dyskaryotic smear or a second borderline smear taken within the Cervical Screening Wales (CSW) programme will be invited to participate in the trial.
Key exclusion criteria	N/A
Date of first enrolment	25/10/2005
Date of final enrolment	31/12/2008

Wolfson Institute

London
EC1M 6BQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/01/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)