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

March 26, 2020 updated by: The Royal Wolverhampton Hospitals NHS Trust

PREGCAL: Pilot Study to Assess Faecal Calprotectin as a Potential Non-invasive Inflammatory Marker in Pregnancy and Inflammatory Bowel Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Pregnancy has an interesting and different impact on inflammatory conditions that have much in common immunologically. In inflammatory bowel disease 33% will deteriorate, 33% will remain stable and 33% will improve. In rheumatoid arthritis 75% of women will improve. Gut microbiota alters significantly in pregnancy as do predominant immunological pathways and relapse post-partum is swift. Research on intestinal microbiota in women with inflammatory conditions is scant. The high remission rate in pregnancy gives us a unique opportunity to study the microbiota for changing patterns that could be identified in the future as potential therapeutic targets.

The study aims to identify any bacterial changes from pre-conception through pregnancy to post-partum and comparing women who relapse with rheumatoid arthritis to those who remain in remission.

Clinical condition will be assessed and stool and serum samples will be obtained from women during each trimester during pregnancy for analysis of serum and fecal biomarkers and for microbiota 16S rRNA (ribosomal ribonucleic acid) techniques. Group-specific 16S rRNA-targeted oligonucleotide probes labeled with the fluorescent dye Cy3 will be used for enumerating bacteria. The probes used will determine bifidobacteria, bacteroides, clostridia (Clostridium perfringens/histolyticum sub. Grp.), eubacterium recale-C histolyticum sub gp., agrobacterium rimae - Collinsella-Eggerthella lenta sub. Gp., Lactobacillus/Enterococcus spp., desulfovibrio spp., Faecalibacterium prausnitzii and Escherichia coli, interferon-gamma and Interleukin 10 (IL-10). Total bacteria will be enumerated using flow cytometry techniques.

The outcomes of this project would help identify microbiota patterns and bacteria species that are beneficial in rheumatoid arthritis and could be targets for potential gut immunomodulation therapy in the future to prolong periods of remissions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Wolverhampton, United Kingdom, WV10 0QP
        • The Royal Wolverhampton NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measure faecal calprotectin in pregnant IBD patients and compare to healthy controls
Time Frame: 24 Months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess elevated f-CP in pregnant, healthy patients
Time Frame: 24 months
If pregnant healthy patients have elevated f-CP levels outwith the standard range for normal. If they do not, then demonstrating that against an IBD cohort may mean that they can be used as surrogate markers of inflammation even in pregnancy
24 months
Assess elevated f-CP levels in IBD patients
Time Frame: 24 months
If the f-CP levels are raised if they compare with those of IBD patients, and therefore the marker becomes unreliable or if there is a difference, could lead to a larger national study to quantify sensitivity and specificity of the test in this group of patients
24 months
Measure serum calprotectin levels in faeces
Time Frame: 24 Months
Measurements for serum calprotectin will also be taken to compare to faecal levels and see if they correlate to fluctuate at different times during pregnancy
24 Months
Assess elevated f-SA12 levels in pregnant, healthy patients
Time Frame: 24 months
If pregnant healthy patients have elevated f-SA12 levels outwith the standard range for normal. If they do not, then demonstrating that against an IBD cohort may mean that they can be used as surrogate markers of inflammation even in pregnancy
24 months
Assess elevated f-SA12 levels in IBD patients
Time Frame: 24 Months
If the f-SA12 levels are raised if they compare with those of IBD patients, and therefore the marker becomes unreliable or if there is a difference, could lead to a larger national study to quantify sensitivity and specificity of the test in this group of patients
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Royal Wolverhampton Hospitals NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Helen Steed, The Royal Wolverhampton NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015GAS78

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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