Inflammatory Bowel Disease (IBD)PREGCALNCT02778464
Faecal Calprotectin as a Potential Non-invasive Inflammatory Marker in Pregnancy and Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease (IBD) and Crohn's Disease (CD), run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Crohn's Disease (CD), Ulcerative Colitis (UC)
- How many people
- 63 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Nov 2016to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Active infection
- NSAID, aspirin or anticoagulant us,
- Recipients of antibiotics in under 4 weeks of initial trial participation
- Women on the oral contraceptive pill
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP
About this study
Official title: 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.
Read the 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.
- 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)
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Months
Secondary outcomes (5)
Assess elevated f-CP in pregnant, healthy patients
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
Measured: 24 months
Assess elevated f-CP levels in IBD patients
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
Measured: 24 months
Measure serum calprotectin levels in faeces
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
Measured: 24 Months
Assess elevated f-SA12 levels in pregnant, healthy patients
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
Measured: 24 months
Assess elevated f-SA12 levels in IBD patients
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
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study start8 Nov 2016
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Helen Steed, Principal investigator, The Royal Wolverhampton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778464
- Sponsor's protocol ID
- 2015GAS78
- Acronym
- PREGCAL
- Status last verified
- Mar 2020
- First submitted
- 5 Apr 2016
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREGCAL: Pilot Study to Assess Faecal Calprotectin as a Potential Non-invasive Inflammatory Marker in Pregnancy and Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02778464
- Acronym / sponsor ID
- PREGCAL / 2015GAS78
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- Coeliac disease
- Familial adenomatous polyposis and hereditary nonpolyposis
- Rheumatoid arthritis (in healthy group or IBD groups)
- Irritable bowel syndrome (ROME III criteria)
- Lactose intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Assess elevated f-CP in pregnant, healthy patients
Time frame: 24 months
Assess elevated f-CP levels in IBD patients
Time frame: 24 months
Measure serum calprotectin levels in faeces
Time frame: 24 Months
Assess elevated f-SA12 levels in pregnant, healthy patients
Time frame: 24 months
Assess elevated f-SA12 levels in IBD patients
Time frame: 24 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Steed principal investigator
The Royal Wolverhampton NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (IBD) and Crohn's Disease (CD), run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure faecal calprotectin in pregnant IBD patients and compare to healthy controls (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.