Pregnancy Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Enrolling by invitation |
NCT05415371 -
Persistent Poverty Counties Pregnant Women With Medicaid
|
N/A | |
Completed |
NCT04548102 -
Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman
|
N/A | |
Completed |
NCT03218956 -
Protein Requirement During Lactation
|
N/A | |
Completed |
NCT02191605 -
Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy
|
N/A | |
Completed |
NCT02223637 -
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
|
||
Recruiting |
NCT06049953 -
Maternal And Infant Antipsychotic Study
|
||
Completed |
NCT02577536 -
PregSource: Crowdsourcing to Understand Pregnancy
|
||
Not yet recruiting |
NCT06336434 -
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05412238 -
Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months
|
N/A | |
Not yet recruiting |
NCT04786587 -
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
|
||
Not yet recruiting |
NCT05028387 -
Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
|
||
Completed |
NCT02783170 -
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
|
Phase 4 | |
Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 | |
Recruiting |
NCT02564250 -
Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women
|
N/A | |
Recruiting |
NCT02619188 -
Nutritional Markers in Normal and Hyperemesis Pregnancies
|
N/A | |
Recruiting |
NCT02507180 -
Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
|
||
Terminated |
NCT02537145 -
PregnanT Moms Measure - Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women
|