Non Alcoholic SteatohepatitisPhase 2SYNCHNCT05821010
Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis
A Phase 2 study testing Lyophilized fecal microbiota transplantation capsules, A. soehngenii and Pasteurized A. muciniphila in people with Non Alcoholic Steatohepatitis and Non-Alcoholic Fatty Liver Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to investigate the therapeutic potential of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and fructo-oligosaccharides with and without conditioned vegan lyophilized fecal microbiota transplantation capsules to reduce NASH in patients with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease, Fecal Microbiota Transplantation
- What is being tested?
- Lyophilized fecal microbiota transplantation capsules, A. soehngenii and Pasteurized A. muciniphila
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Mar 2023to 20 Aug 2026
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- biopsy-proven NASH obtained up to 32 weeks before screening: SAF Steatosis score ≥1, Activity ≥2, Fibrosis <4; 50% of participants should at least have NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on tandem reading of two expert liver pathologists
- fluency in Dutch or English
- participants should be able to understand the information and give informed consent
Who cannot join
- Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year before screening (significant alcohol consumption is defined as more than 2 international units/day for females and more than 3 international units/day for males, on average; 1 international unit contains ±14 grams of alcohol)
- liver cirrhosis or hepatocellular carcinoma
- hepatitis B and/or C
- auto-immune hepatitis
- Wilson's disease
- primary sclerosing cholangitis
Show all 24Show fewer
- primary biliary cholangitis
- alpha-1-antitripsine deficiency and hemochromatosis
- history of liver transplant, current placement on a liver transplant list
- use of pre-, pro- or synbiotics
- use of systemic antibiotics 3 month prior to randomization
- use of tamoxifen, methotrexate or amiodarone
- prior or planned bariatric surgery
- active GLP-1 receptor agonist treated diabetes mellitus
- bleeding disorder
- International normalized ratio (INR) of prothrombin time >1.4 or platelet count <100 109/L at screening
- anti-platelet/coagulant therapy use which cannot be temporarily discontinued
- any major cardiovascular event within 6 months prior to screening (e.g. myocardial infarction, cerebrovascular accident)
- prolonged compromised immunity (e.g. recent cytotoxic chemotherapy, HIV-infection with a CD4 count < 240)
- active or prior history of invasive malignancy (except for curatively treated in situ carcinomas [e.g., cervix] or non-melanoma skin cancer) unless a complete remission was achieved
- surgery scheduled for the trial duration period, except for minor surgical procedures, in the opinion of the investigator
- pregnant or nursing women
- any condition which, in the investigator's opinion, might jeopardize participants' safety or compliance with the protocol
- participation in another concomitant clinical trial.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1105AZ
Q.J.J. Augustijn, MD, +315661267, q.j.augustijn@amsterdamumc.nl
About this study
The goal of this clinical trial is to investigate the therapeutic potential of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and fructo-oligosaccharides with and without conditioned vegan lyophilized fecal microbiota transplantation capsules to reduce NASH in patients with fibrotic NASH. The main questions to answer are:
- Can NASH be treated by altering the gut microbiota using LFMT capsules?
- Can NASH be treated using a syntrophic cocktail of synbiotics and will these strains strengthen the effect of FMT?
- What are the underlying mechanism by which the aforementioned treatments attenuate NASH?
Participants will be treated with FMT-capsules or placebo, and all participants will receive a cocktail of 3 strains of probiotics and one type of prebiotic.
Read the detailed description
Main objective To investigate the therapeutic potential of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and fructo-oligosaccharides with and without conditioned vegan lyophilized fecal microbiota transplantation (LFMT) capsules to reduce NASH in patients with NASH and NASH-fibrosis.
Secondary objective To investigate the mechanisms of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and FOS with and without conditioned vegan LFMT capsules in reducing NASH in patients with NASH and NASH-fibrosis.
Study design:
Double-blind randomized placebo-controlled intervention study.
Study population:
Patients between age 18-75 years with biopsy-proven NASH obtained up to 32 weeks before screening based on tandem reading of two expert liver pathologists: SAF Steatosis score ≥1, Activity ≥2, Fibrosis <4; 50% of participants should at least have NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system.
Intervention:
Recipient participants From day -3 before the first FMT until completion of the study, all recipient participants will receive an oral daily single dose of 5 g FOS. Subsequently, participants will be randomized to lean donor FMT capsules (donors conditioned with WholeFiber) or placebo (blinded design)1.
At baseline (day 0) and at week 8 (day 56) and week 16 (day 112) participants will ingest 21 LFMT or placebo capsules. The study visits will be 8 weeks apart, although a margin of -3 days to +3 days is implemented to take participants schedule and availability into account. In addition, participants will daily take 2 capsules of LFMT or placebo during the whole study period (24 weeks).
The investigators have previously observed that gut microbiota composition in the recipient is affected up to 8-12 weeks after donor FMT1, so this time window ensures a stable donor gut microbiota composition during the study.
During the 24-week intervention period, all participants will take daily doses of 109 A. soehngenii CH-106 cells (dosage based on previous studies including toxicology study)2,3, 1010 B. animalis subsp. lactis BLC1 (a well-studied strain marketed as a probiotic by Sacco SRL) and 3x1010 pasteurized A. muciniphila ATCC BAA-835T cells (dosage based on EFSA approval and obtained from A-Mansia Biotech).
Percutaneous liver biopsies will be performed as a part of screening when participants are theoretically eligible for participation, unless a liver biopsy has been performed in the previous 36 weeks. A tandem-read by two liver pathologists blinded to any other result will determine if patients will be included in the study. At 24 weeks, another liver biopsy will be performed to examine the effect of the FMT, which will also be reviewed by two liver pathologists (again blinded to any other result). The NASH-CRN classification will be assessed on H\&E slides, for steatosis, inflammation and ballooning, and with a Sirius red-stained slide for evaluation of fibrosis. RNA for RNA-sequencing will be isolated.
Differential gene expression will be assessed over time (baseline and 24 weeks) and by treatment allocation (vegan donor FMT versus placebo).
Feces will be collected at baseline, and after week 2, 8, 10, 16, 18, and 24, in order to investigate the changes in gut microbiome. Also, markers of gut barrier function will be assessed.
Blood will be collected at baseline and at 8, 16 and 24 weeks to investigate common liver enzymes, indicators of glycemic control, lipids, and general and more NASH-specific inflammation parameters.
A multiparametric MRI of liver (MRI-PDFF, MR elastography, corrected T1) and of visceral and subcutaneous fat will be performed at baseline and after 24 weeks to estimate visceral and subcutaneous adipose tissue depot volume, hepatic fat content as well as hepatic fibrosis and inflammation.
Continuous glucose measurements will be performed at home using portable devices, during a consecutive period of 1 week (7 days) in the week before baseline, week 1, 9, 17 and 25.
- Conditions
- Non Alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease, Fecal Microbiota Transplantation, FMT, Prebiotics, Probiotics
- Being tested
- Lyophilized fecal microbiota transplantation capsules, Placebo capsules, A. soehngenii, Pasteurized A. muciniphila, B. animalis subsp. lactis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyophilized fecal microbiota transplantation capsulesCombination product
Oral administration (capsule)
Placebo capsulesCombination product
Oral administration (capsule)
A. soehngeniiDietary supplement
Oral administration (capsule)
Pasteurized A. muciniphilaDietary supplement
Oral administration (capsule)
B. animalis subsp. lactisDietary supplement
Oral administration (capsule)
Fructo-oligosaccharidesDietary supplement
Oral administration (dissolved in water)
| Study group | Role | What they receive |
|---|---|---|
| LFMT-capsules | Experimental | LFMT-capsules. 3 times bulk, and further continuous administration. This arm is also treated pre- and probiotics. Receives: Combination Product: Lyophilized fecal microbiota transplantation capsules; Dietary Supplement: A. soehngenii; Dietary Supplement: Pasteurized A. muciniphila; Dietary Supplement: B. animalis subsp. lactis; Dietary Supplement: Fructo-oligosaccharides |
| Placebo | Placebo comparator | Placebo-capsules. 3 times bulk, and further continuous administration. This arm is also treated pre- and probiotics. Receives: Combination Product: Placebo capsules; Dietary Supplement: A. soehngenii; Dietary Supplement: Pasteurized A. muciniphila; Dietary Supplement: B. animalis subsp. lactis; Dietary Supplement: Fructo-oligosaccharides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver histology
Alteration of liver histology in subjects with NASH and fibrosis stage 0-3, with an alteration defined as change of steatohepatitis by ≥1 SAF-A point, or a change in ≥ 1 stage liver fibrosis.
Measured: baseline and after 24 weeks
Secondary outcomes (19)
MRI
MRI-PDFF, MR elastography, corrected T1
Measured: baseline and after 24 weeks
Fibroscan
CAP and LSM
Measured: baseline and after 24 weeks
Liver enzymes (blood)
alanine amino transferase (ALT), aspartate amino transferase (AST), gamma glutamyl transferase (GGT), alkaline phosphatase (ALP))
Measured: baseline and after 24 weeks; 8 and 16 weeks for safety.
Immunological data
leukocytes, monocytes, CRP, Il-1(β), Il-6, Il-11, Il-17, Il-32, TNF-α, IFN-γ, other inflammatory markers),
Measured: baseline and after 24 weeks
Plasma lipids
plasma lipids (LDL, HDL, triglycerides, total cholesterol),
Measured: baseline and after 24 weeks
Gut metabolites (in blood)
short chain fatty acids (i.e. propionate, butyrate, acetate), lactate, ethanol,
Measured: baseline and after 24 weeks
Glycemic control
Continuous glucose monitoring (4x 7 consecutive days), HOMA-IR
Measured: 5 weeks during study period
albumin, kreatinine, hemoglobin (blood)
albumin, kreatinine, hemoglobin (blood)
Measured: baseline, 8, 16 and 24 weeks
NAFLD NASH related endocrinological and metabolic outcome parameters
FGF-21, adiponectin, leptin, lipopolysaccharides, estrogen, vitamin B12, folate acid, zonulin, and other metabolomic and lipidomic outcomes.
Measured: Baseline and 24 weeks
Microbiome readouts
microbiome read outs (composition, engraftment, strain tracking) and metabolites, fecal SCFA-composition, and fecal albumine.
Measured: baseline and after 24 weeks, and 5 times in between.
Body weight
Body weight measured without shoes, in kilograms
Measured: baseline and after 24 weeks
Height
Height measured without shoes, in cm
Measured: baseline
BMI
Body mass index, calculated from height and weight kg/m^2 (kg per meters squared)
Measured: baseline and after 24 weeks
Waist circumference
Measured just cranial of the spina iliaca anterior superior, in cm
Measured: baseline and after 24 weeks
Percentage body fat
Measured with a biometric device, as a percentage.
Measured: baseline and after 24 weeks
Demographics and (medical) history
Sex, age, ethnicity, height, weight, comorbidities (e.g. diabetes), smoking, alcohol intake, medication use, polypharmacy (defined as chronic use of ≥ 5 different medications)
Measured: baseline and 24 weeks
Quality of life with CDLQ-NASH
quality of life with NAFLD/NASH-specific (CDLQ-NAFLD)) questionnaire.
Measured: baseline and after 24 weeks
Quality of life with SF36 questionnaire.
quality of life (general (SF36) questionnaire.
Measured: baseline and after 24 weeks
Food diary
5x 10 days, daily caloric intake, daily fat and sugar consumption
Measured: around the visits 0, 8, 16, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start17 Mar 2023
- Primary completion20 Feb 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Alcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onno Holleboom, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- A.G. Holleboom, MD, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821010
- Sponsor's protocol ID
- NL81001.018.22
- Acronym
- SYNCH
- Status last verified
- Aug 2024
- First submitted
- 8 Mar 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Augustijn QJJ, Grefhorst A, de Groen P, Wortelboer K, Seegers JFM, Gul IS, Suenaert P, Verheij J, de Vos WM, Herrema H, Nieuwdorp M, Holleboom AG. Randomised double-blind placebo-controlled trial protocol to evaluate the therapeutic efficacy of lyophilised faecal microbiota capsules amended with next-generation beneficial bacteria in individuals with metabolic dysfunction-associated steatohepatitis. BMJ Open. 2025 Jan 9;15(1):e088290. doi: 10.1136/bmjopen-2024-088290.
PubMed 39788762
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT05821010
- Acronym / sponsor ID
- SYNCH / NL81001.018.22
- Conditions
- Non Alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease, Fecal Microbiota Transplantation, FMT, Prebiotics, Probiotics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 20 Apr 2023 (actual)
- 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.
The goal of this clinical trial is to investigate the therapeutic potential of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and fructo-oligosaccharides with and without conditioned vegan lyophilized fecal microbiota transplantation capsules to reduce NASH in patients with fibrotic NASH. The main questions to answer are:
- Can NASH be treated by altering the gut microbiota using LFMT capsules?
- Can NASH be treated using a syntrophic cocktail of synbiotics and will these strains strengthen the effect of FMT?
- What are the underlying mechanism by which the aforementioned treatments attenuate NASH?
Participants will be treated with FMT-capsules or placebo, and all participants will receive a cocktail of 3 strains of probiotics and one type of prebiotic.
Detailed description
Main objective To investigate the therapeutic potential of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and fructo-oligosaccharides with and without conditioned vegan lyophilized fecal microbiota transplantation (LFMT) capsules to reduce NASH in patients with NASH and NASH-fibrosis.
Secondary objective To investigate the mechanisms of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and FOS with and without conditioned vegan LFMT capsules in reducing NASH in patients with NASH and NASH-fibrosis.
Study design:
Double-blind randomized placebo-controlled intervention study.
Study population:
Patients between age 18-75 years with biopsy-proven NASH obtained up to 32 weeks before screening based on tandem reading of two expert liver pathologists: SAF Steatosis score ≥1, Activity ≥2, Fibrosis <4; 50% of participants should at least have NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system.
Intervention:
Recipient participants From day -3 before the first FMT until completion of the study, all recipient participants will receive an oral daily single dose of 5 g FOS. Subsequently, participants will be randomized to lean donor FMT capsules (donors conditioned with WholeFiber) or placebo (blinded design)1.
At baseline (day 0) and at week 8 (day 56) and week 16 (day 112) participants will ingest 21 LFMT or placebo capsules. The study visits will be 8 weeks apart, although a margin of -3 days to +3 days is implemented to take participants schedule and availability into account. In addition, participants will daily take 2 capsules of LFMT or placebo during the whole study period (24 weeks).
The investigators have previously observed that gut microbiota composition in the recipient is affected up to 8-12 weeks after donor FMT1, so this time window ensures a stable donor gut microbiota composition during the study.
During the 24-week intervention period, all participants will take daily doses of 109 A. soehngenii CH-106 cells (dosage based on previous studies including toxicology study)2,3, 1010 B. animalis subsp. lactis BLC1 (a well-studied strain marketed as a probiotic by Sacco SRL) and 3x1010 pasteurized A. muciniphila ATCC BAA-835T cells (dosage based on EFSA approval and obtained from A-Mansia Biotech).
Percutaneous liver biopsies will be performed as a part of screening when participants are theoretically eligible for participation, unless a liver biopsy has been performed in the previous 36 weeks. A tandem-read by two liver pathologists blinded to any other result will determine if patients will be included in the study. At 24 weeks, another liver biopsy will be performed to examine the effect of the FMT, which will also be reviewed by two liver pathologists (again blinded to any other result). The NASH-CRN classification will be assessed on H\&E slides, for steatosis, inflammation and ballooning, and with a Sirius red-stained slide for evaluation of fibrosis. RNA for RNA-sequencing will be isolated.
Differential gene expression will be assessed over time (baseline and 24 weeks) and by treatment allocation (vegan donor FMT versus placebo).
Feces will be collected at baseline, and after week 2, 8, 10, 16, 18, and 24, in order to investigate the changes in gut microbiome. Also, markers of gut barrier function will be assessed.
Blood will be collected at baseline and at 8, 16 and 24 weeks to investigate common liver enzymes, indicators of glycemic control, lipids, and general and more NASH-specific inflammation parameters.
A multiparametric MRI of liver (MRI-PDFF, MR elastography, corrected T1) and of visceral and subcutaneous fat will be performed at baseline and after 24 weeks to estimate visceral and subcutaneous adipose tissue depot volume, hepatic fat content as well as hepatic fibrosis and inflammation.
Continuous glucose measurements will be performed at home using portable devices, during a consecutive period of 1 week (7 days) in the week before baseline, week 1, 9, 17 and 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| LFMT-capsules | Experimental | Combination Product: Lyophilized fecal microbiota transplantation capsules, Dietary Supplement: A. soehngenii, Dietary Supplement: Pasteurized A. muciniphila, Dietary Supplement: B. animalis subsp. lactis, Dietary Supplement: Fructo-oligosaccharidesLFMT-capsules. 3 times bulk, and further continuous administration. This arm is also treated pre- and probiotics. |
| Placebo | Placebo comparator | Combination Product: Placebo capsules, Dietary Supplement: A. soehngenii, Dietary Supplement: Pasteurized A. muciniphila, Dietary Supplement: B. animalis subsp. lactis, Dietary Supplement: Fructo-oligosaccharidesPlacebo-capsules. 3 times bulk, and further continuous administration. This arm is also treated pre- and probiotics. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- biopsy-proven NASH obtained up to 32 weeks before screening: SAF Steatosis score ≥1, Activity ≥2, Fibrosis <4; 50% of participants should at least have NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on tandem reading of two expert liver pathologists
- fluency in Dutch or English
- participants should be able to understand the information and give informed consent
Key exclusion criteria (24 listed)
- Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year before screening (significant alcohol consumption is defined as more than 2 international units/day for females and more than 3 international units/day for males, on average; 1 international unit contains ±14 grams of alcohol)
- liver cirrhosis or hepatocellular carcinoma
- hepatitis B and/or C
- auto-immune hepatitis
- Wilson's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lyophilized fecal microbiota transplantation capsulesOral administration (capsule) | Combination product | LFMT-capsules |
| Placebo capsulesOral administration (capsule) | Combination product | Placebo |
| A. soehngeniiOral administration (capsule) | Dietary supplement | LFMT-capsules, Placebo |
| Pasteurized A. muciniphilaOral administration (capsule) | Dietary supplement | LFMT-capsules, Placebo |
| B. animalis subsp. lactisOral administration (capsule) | Dietary supplement | LFMT-capsules, Placebo |
| Fructo-oligosaccharidesOral administration (dissolved in water) | Dietary supplement | LFMT-capsules, Placebo |
Primary outcome
Liver histology
Time frame: baseline and after 24 weeks
Alteration of liver histology in subjects with NASH and fibrosis stage 0-3, with an alteration defined as change of steatohepatitis by ≥1 SAF-A point, or a change in ≥ 1 stage liver fibrosis.
19 secondary outcomes
MRI
Time frame: baseline and after 24 weeks
Fibroscan
Time frame: baseline and after 24 weeks
Liver enzymes (blood)
Time frame: baseline and after 24 weeks; 8 and 16 weeks for safety.
Immunological data
Time frame: baseline and after 24 weeks
Plasma lipids
Time frame: baseline and after 24 weeks
Gut metabolites (in blood)
Time frame: baseline and after 24 weeks
Glycemic control
Time frame: 5 weeks during study period
albumin, kreatinine, hemoglobin (blood)
Time frame: baseline, 8, 16 and 24 weeks
NAFLD NASH related endocrinological and metabolic outcome parameters
Time frame: Baseline and 24 weeks
Microbiome readouts
Time frame: baseline and after 24 weeks, and 5 times in between.
Body weight
Time frame: baseline and after 24 weeks
Height
Time frame: baseline
BMI
Time frame: baseline and after 24 weeks
Waist circumference
Time frame: baseline and after 24 weeks
Percentage body fat
Time frame: baseline and after 24 weeks
Demographics and (medical) history
Time frame: baseline and 24 weeks
Quality of life with CDLQ-NASH
Time frame: baseline and after 24 weeks
Quality of life with SF36 questionnaire.
Time frame: baseline and after 24 weeks
Food diary
Time frame: around the visits 0, 8, 16, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Derived from this study: PubMed 39788762Augustijn QJJ, Grefhorst A, de Groen P, Wortelboer K, Seegers JFM, Gul IS, Suenaert P, Verheij J, de Vos WM, Herrema H, Nieuwdorp M, Holleboom AG. Randomised double-blind placebo-controlled trial protocol to evaluate the therapeutic efficacy of lyophilised faecal microbiota capsules amended with next-generation beneficial bacteria in individuals with metabolic dysfunction-associated steatohepatitis. BMJ Open. 2025 Jan 9;15(1):e088290. doi: 10.1136/bmjopen-2024-088290.
- 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.
A.G. Holleboom, MD, PhD principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lyophilized fecal microbiota transplantation capsules, A. soehngenii and Pasteurized A. muciniphila in people with Non Alcoholic Steatohepatitis and Non-Alcoholic Fatty Liver Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 3 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. 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 Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quinten Augustijn, MD (+31205661267, q.j.augustijn@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver histology (time frame: baseline and after 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05821010, which also lists 1 linked publication.
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 Aug 2024.