Microbiota and Bone Fragility:Study of the Relation Between Gut Microbiota and Bone Microarchitecture
-
- STATUS
- Recruiting
-
- participants needed
- 440
-
- sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Summary
Gut microbiota regulate metabolism of their human host. Some diseases are associated with variations in gut microbiota diversity and higher fracture risk. Intestinal bacteria synthesize or influence synthesis of factors modulating bone metabolism. The link between gut microbiota and bone was assessed mainly in experimental animal studies. Clinical data, e.g. on the role of gut microbiota in postmenopausal osteoporosis are scarce. The investigators will compare gut microbiota composition in four groups of women aged 60 recruited on the basis of bone mineral density (BMD) and personal history of fracture. the participants will have diagnostic exams: clinical tests, bone densitometry (body composition, vertebral fractures), high resolution peripheral QCT (bone strength estimated by microfinite element analysis, micro-FEA), biological sample collection. Gut microbiome profiling will be performed at the INRA MetaGenoPolis laboratory. The investigators will compare gut microbiota diversity according to BMD level and to the fracture status. The investigators will analyze interactions of the gut microbiota diversity with bone status (bone turnover rate, BMD, bone microarchitecture, bone strength estimated by micro-FEA), muscle mass and strength, inflammatory cytokines and micro-RNAs modulating their expression. This study will provide new data concerning the importance of gut microbiota for the fracture risk in older women. It will help to identify the main metabolic pathways underlying the observed associations.
Description
Postmenopausal osteoporosis is a major public health problem in developed countries. Despite the progress, knowledge of its pathophysiological mechanisms and identification of women at high risk of fracture in the clinical practice are not satisfactory. Gut microbiota consist of trillions of commensal bacteria playing a major role in the regulation of metabolism of their human host. Some conditions (diabetes mellitus, obesity, liver cirrhosis, inflammatory bowel disease, end stage renal disease, depression, heavy drinking, heavy smoking) are associated with variations in gut microbiota diversity and higher risk of fracture. Intestinal bacteria synthesize or influence the synthesis of factors which modulate bone metabolism, e.g. lipopolysaccharide (present in the wall of Gram-negative bacteria), inflammatory cytokines (synthesized in the gut associated lymphoid tissue), serotonin (synthesized in the colon epithelium), short-chain fatty acids, estrogens (deconjugation of sulphates and glucuronides). Data on the association between gut microbiota and bone metabolism were obtained mainly in experimental animal studies. Clinical data are limited. Data on the possible role of gut microbiota in the pathophysiology of the postmenopausal osteoporosis are scarce.
The investigators will carry out a cross-sectional comparison of gut microbiota composition in four groups of women aged 60 and over recruited on the basis of their bone mineral density (BMD) and personal history of fragility fracture. The primary statistical analyses will be focused on the comparison of gut microbiota diversity according to BMD (in women with the same fracture status) and according to the fracture status (in women with similar BMD). The investigators will analyze interactions of the gut microbiota diversity, its metabolic activity and other metabolic factors on the one hand, with bone status on the other hand. The investigators will study the association of gut microbiota composition with bone turnover rate, BMD, bone microarchitecture, bone strength estimated by microfinite element analysis (micro-FEA) and with physical performance, muscle mass and strength. The investigators will assess the impact of microRNAs modulating the expression of inflammatory cytokines on the serum levels of these cytokines according to the pattern of gut microbiota diversity and their associations with the characteristics of bone status (e.g. bone microarchitecture). The investigators will analyze the association between serum serotonin, abundance of intestinal bacteria stimulating serotonin synthesis (some Clostridia species) in the colon and the characteristics of bone status.
This study will provide new data concerning the importance of gut microbiota for the fracture risk in older women. The main limitation of this study is its cross-sectional design but this is the first clinical study exploring this subject. It will help to identify the main metabolic pathways underlying the observed associations. These data will stimulate experimental studies to elucidate biological mechanisms underlying these associations. the results will provide indications for future clinical and experimental studies. In the long run, the results will lead up to future studies permitting to develop new biological markers of fracture risk in older women and new anti-osteoporotic medications.
Details
| Condition | Osteoporosis, Osteoporosis |
|---|---|
| Age | 60-100 years |
| Treatment | Questionnaires, bone densitometry, High resolution peripheral QCT, Collection of biological samples, clinical tests |
| Clinical Study Identifier | NCT04265742 |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
| Last Modified on | 19 February 2024 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer
Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!
No annotations made yet
Add a private note
- Select a piece of text from the left.
- Add notes visible only to you.
- Send it to people through a passcode protected link.
Study Definition
WikipediaAdd a private note
- Select a piece of text.
- Add notes visible only to you.
- Send it to people through a passcode protected link.