Leaking of bacterial products from the intestine into the circulation can cause inflammation of the joints of the hand. We presume that preparations of slow release calcium butyrate can stop this leakage. This will result in less inflammation and in less pain.

Role of the intestine on osteoarthritis of the hand and the effect of Sustained Release Calcium Butyrate. - Intestine and osteoarthritis

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001071-33-NL

Enrollment

Registered

2021-12-03

Start date

2022-02-03

Completion date

Unknown

Last updated

2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the hand

Interventions

Product Name: sustained release calcium butyrate Product Code: CRCABU150 Pharmaceutical Form: Tablet INN or Proposed INN: sustaine release calcium butyrate CAS Number: 5743-36-2 Other descriptive name

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 50 year and = 75 years, - Osteoarthritis of the hand according to the 1990 ACR diagnostic criteria for hand OA (Altman 1990) in both hands operationalized as: • Hand pain, aching, or stifness and 3 or 4 of the following: • Hard tissue enlargement of 2 or more of 10 selected joints • Hard tissue enlargement of 2 or more DIP joints • Fewer than 3 swollen MCP joints • Deformity of at least 1 of 10 selected joints. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 33 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 33

Exclusion criteria

Exclusion criteria: - Recent use of antibiotics (last three months) - Previous surgery of one of the hands - Recent cerebro- or cardiovascular incident (past 6 months) - Diabetes - Other chronic inflammatory disease - Other musculoskeletal diseases than OA with possible hand localisation - Cognitive deficits affecting the scoring process - Received intramuscular of intra-articular corticosteroid injections in the previous 4 weeks - Fibromyalgia according to the 2010 ACR diagnostic criteria for fibromyalgia (Wolfe 2011) - Any other syndrome(s) or condition(s) that could interfere with the assessment of pain - Severe current psychiatric disorders assessed by physician - Self-reported consumption of alcoholic drinks, > 2 units per day

Design outcomes

Primary

Measure	Time frame
Primary end point(s): A positive treatment effect with respect to microbiome composition and function is an increase in alpha diversity and fraction of strict anaerobes. More specifically, this entails increase in relative abundance of members of the Lachnospiraceae and Ruminococcaceae, including populations of butyrate producers such as Faecalibacterium prausnitzii, and an increase in the abundance of functional genes encoding enzymes involved in butyrate production. Furthermore, a positive treatment effect is a decrease in the abundance of Enterobacteriaceae and genus Streptococcus, and a decrease in genes involved in virulence, LPS production and gut barrier toxin production.;Timepoint(s) of evaluation of this end point: before start of treartment and ater 4 - 5 treatment weeks;Main Objective: This proof of concept study is to estimate the effect of SRCaBu (600 mg daily for four weeks) on compositional and functional characteristics of the microbiome for future sample size calculation;Secondary Objective: 1) To evaluate the short-term effects (i.e. 4 5 weeks) of SRCaBu (600 mg dd) compared with placebo on pain and functioning of the hands in hand OA patients. 2) To evaluate whether SRCaBu (600 mg dd) lowers systemic inflammation in hand OA. 3) To evaluate whether immune tolerance will improve while lowering inflammation by characterizing the phenotype of T-cells and monocytes and determining the response of activated PBMCs of patients before and after intake of 600 mg dd SRCaBu. 4) To examine the safety profile of (600 mg dd) SRCaBu in patients with hand OA over 4- 5 weeks. 5) To examine the association between intestine functioning and pain and functioning of the hands in hand OA patients.	—

Measure

Time frame

Primary end point(s): A positive treatment effect with respect to microbiome composition and function is an increase in alpha diversity and fraction of strict anaerobes. More specifically, this entails increase in relative abundance of members of the Lachnospiraceae and Ruminococcaceae, including populations of butyrate producers such as Faecalibacterium prausnitzii, and an increase in the abundance of functional genes encoding enzymes involved in butyrate production. Furthermore, a positive treatment effect is a decrease in the abundance of Enterobacteriaceae and genus Streptococcus, and a decrease in genes involved in virulence, LPS production and gut barrier toxin production.;Timepoint(s) of evaluation of this end point: before start of treartment and ater 4 - 5 treatment weeks;Main Objective: This proof of concept study is to estimate the effect of SRCaBu (600 mg daily for four weeks) on compositional and functional characteristics of the microbiome for future sample size calculation;Secondary Objective: 1) To evaluate the short-term effects (i.e. 4 5 weeks) of SRCaBu (600 mg dd) compared with placebo on pain and functioning of the hands in hand OA patients. 2) To evaluate whether SRCaBu (600 mg dd) lowers systemic inflammation in hand OA. 3) To evaluate whether immune tolerance will improve while lowering inflammation by characterizing the phenotype of T-cells and monocytes and determining the response of activated PBMCs of patients before and after intake of 600 mg dd SRCaBu. 4) To examine the safety profile of (600 mg dd) SRCaBu in patients with hand OA over 4- 5 weeks. 5) To examine the association between intestine functioning and pain and functioning of the hands in hand OA patients.

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Secondary

Measure	Time frame
Secondary end point(s): barrier function intestine, variables related to systemic inflammation; Variables related to systemic inflammation are: hsCRP, il-1ß, il-6, sTNFR1 en sTNFR2, TNF?, leptin, uric acid and NOx,; Variables related to immune tolerance and inflammatory responses are: Treg/Th17 balance, activated Th17 and Th1, M1/M2 balance. pain and functioning of hand joints, patiente global assessment, quality of life, defecation ;Timepoint(s) of evaluation of this end point: All variablble before start of treatment, all variables afte 4-5 treatment weeks Pain, joint function, quality of life, defecation daily	—

Measure

Time frame

Secondary end point(s): barrier function intestine, variables related to systemic inflammation; Variables related to systemic inflammation are: hsCRP, il-1ß, il-6, sTNFR1 en sTNFR2, TNF?, leptin, uric acid and NOx,; Variables related to immune tolerance and inflammatory responses are: Treg/Th17 balance, activated Th17 and Th1, M1/M2 balance. pain and functioning of hand joints, patiente global assessment, quality of life, defecation ;Timepoint(s) of evaluation of this end point: All variablble before start of treatment, all variables afte 4-5 treatment weeks Pain, joint function, quality of life, defecation daily

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Countries

Netherlands

Contacts

Public Contactclinical trials

BirrBeheer BV

jan@birr.nl0031646161592

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026