Faecal Calprotectin as a Potential Non-invasive Inflammatory Marker in Pregnancy and Inflammatory Bowel Disease

NCT02778464 | Completed

• 1 other identifier: 2015GAS78
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

When women with rheumatoid arthritis become pregnant 75% of them will go into remission, despite stopping medication. This phenomenon is not well understood and is not seen in other inflammatory conditions. Once they give birth they often relapse. Bacteria in the stool and inside the gut have the ability to effect the immune system and some beneficial bacteria are known to down regulate inflammatory components of the immune system. Gut bacteria are also known to alter significantly during pregnancy and in other inflammatory conditions there are low levels of beneficial bacteria associated with diseases like ulcerative colitis. There is significant crossover between rheumatoid arthritis and inflammatory bowel disease with similar arthritic symptoms and mechanisms of inflammation. There is very limited investigation of gut bacteria and rheumatoid arthritis, but some animal work has shown that treatment with probiotics and prebiotics can improve the condition. The aim of this study is to examine the bacteria in the stool of women who are pregnant with rheumatoid arthritis and identify any significant bacteria changes that might be used to direct future research.

Conditions

Inflammatory Bowel Disease (IBD); Crohn's Disease (CD); Ulcerative Colitis (UC); Pregnancy

Keywords

Inflammatory Bowel Disease; Pregnancy; Stool markers; Calprotectin; Faecal S100A12 (f-SA12); Faecal calprotectin (f-Cp)

Outcome Measures

Primary Outcomes (1)

• Measure faecal calprotectin in pregnant IBD patients and compare to healthy controls

  Measuring faecal calprotectin in pregnant IBD patients and comparing to healthy controls in a feasibility study will see if it may be of use as a marker of intestinal inflammation during pregnancy.

  24 Months

Secondary Outcomes (5)

• Assess elevated f-CP in pregnant, healthy patients

  24 months

• Assess elevated f-CP levels in IBD patients

  24 months

• Measure serum calprotectin levels in faeces

  24 Months

• Assess elevated f-SA12 levels in pregnant, healthy patients

  24 months

• Assess elevated f-SA12 levels in IBD patients

  24 Months

Study Arms (4)

Group A: Female IBD and RA (non-pregnant)

This group will be asked to provide three blood samples, one in each trimester. Stool samples are expected to average 8-10 per participant. All diaries and stool sample consumables for disease activity will be issued at the initial visit. Bloods will be obtained at a hospital visit. Stool samples due between hospital visits will be obtained according to protocol to minimise pre-analytical variance.

Group B: Female IBD

This group will be asked to provide three blood samples, one in each trimester. Stool samples are expected to average 8-10 per participant. All diaries and stool sample consumables for disease activity will be issued at the initial visit. Bloods will be obtained at a hospital visit. Stool samples due between hospital visits will be obtained according to protocol to minimise pre-analytical variance.

Group C: Female - Healthy Pregnant

This group will be asked to provide three blood samples, one in each trimester. Stool samples are expected to average 8-10 per participant. All stool sample consumables will be issued at the initial visit. Bloods will be obtained at a hospital visit. Stool samples due between hospital visits will be obtained according to protocol to minimise pre-analytical variance.

Group D: Female - RA Pregnant

This group will be asked to provide three blood samples, one in each trimester. Stool samples are expected to average 8-10 per participant. All stool sample consumables will be issued at the initial visit. Bloods will be obtained at a hospital visit. Stool samples due between hospital visits will be obtained according to protocol to minimise pre-analytical variance.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women are the basis of this study, both with and without IBD to be able to meet the primary objective. As a feasibility study, there is no data on what levels are to be expected in pregnant women and if those results may vary at different stage of pregnancy. The investigators have chosen a small population size that reflects their anticipated recruitment levels of pregnant IBD patients over 2 years in the West Midlands. The investigators would expect to see 2-3 pregnant IBD patients per annum. Across 7 identified collaborating sites to take part the investigators anticipate there to be between 30-42 patients eligible over a 2 year period.

You may qualify if:

• Healthy pregnant women (i.e. no-IBD and no significant comorbidities). pregnant IBD and rheumatoid women with any class of disease activity, non-pregnant IBD women and Rheumatoid arthritis women aged between 18 and 40.

You may not qualify if:

• Coeliac disease
• Familial adenomatous polyposis and hereditary nonpolyposis
• Rheumatoid arthritis (in healthy group or IBD groups)
• Irritable bowel syndrome (ROME III criteria)
• Lactose intolerance
• Other connective tissue inflammatory diseases
• Active infection
• NSAID, aspirin or anticoagulant us,
• Recipients of antibiotics in under 4 weeks of initial trial participation
• Women on the oral contraceptive pill

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Faecal calprotectin, faecal S100A12, serum S100 and serum calprotectin

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Helen Steed

  The Royal Wolverhampton NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: May 19, 2016
• Study Start: November 8, 2016
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)