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FESTIVAL_Fecal transplantation in Hidradenitis suppurativa : a pilot study

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519003-99-00
Acronym
RBHP 2023 BUISSON
Enrollment
24
Registered
2025-06-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-07

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

Conditions

Hidrdenitis suppurative

Brief summary

Improvement of at least 55% in the IHS4 score (score evaluating the number of nodules, abscesses and fistulas with weighting according to the lesion) compared to the baseline state at the 12th week post FMT (D104 +- 2 days)

Detailed description

Improvement of at least 55% in the IHS4 score (score evaluating the number of nodules, abscesses and fistulas with weighting according to the lesion) compared to the baseline state at the 24th week post FMT, Improvement of at least 50% of lesions (nodules and abscesses) without new draining fistula or abscess (HiSCR50 score) at 12 and 24 weeks post-FMT, Improvement of the HSPGA score compared to the base state by 2 ranks (for example change from severe to mild score), Improvement in pain (VAS) at 12 and 24 weeks post-FMT, Improved flow (VAS) at 12 and 24 weeks post-FMT, Improvement in quality of life (DLQI) at 12 and 24 weeks post-FMT, Number and type of side effects: any adverse event (of any grade according to the CTCAE) that may be linked to FMT must be reported, in particular abdominal pain, transit disorders and bacterial translocations from the day of FMT until 6 months post FMT, Analysis of the fecal microbiota of patients at inclusion and at the 12th week post FMT by sequencing the gene encoding the RNA of the small 16S subunit of the bacterial ribosome (16S RNA), Analysis of the fecal microbiota of donors at the first stool donation by sequencing the gene coding for the RNA of the small 16S subunit of the bacterial ribosome (16S RNA)

Interventions

Sponsors

University Hospital Of Clermont-Ferrand
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Improvement of at least 55% in the IHS4 score (score evaluating the number of nodules, abscesses and fistulas with weighting according to the lesion) compared to the baseline state at the 12th week post FMT (D104 +- 2 days)

Secondary

MeasureTime frame
Improvement of at least 55% in the IHS4 score (score evaluating the number of nodules, abscesses and fistulas with weighting according to the lesion) compared to the baseline state at the 24th week post FMT, Improvement of at least 50% of lesions (nodules and abscesses) without new draining fistula or abscess (HiSCR50 score) at 12 and 24 weeks post-FMT, Improvement of the HSPGA score compared to the base state by 2 ranks (for example change from severe to mild score), Improvement in pain (VAS) at 12 and 24 weeks post-FMT, Improved flow (VAS) at 12 and 24 weeks post-FMT, Improvement in quality of life (DLQI) at 12 and 24 weeks post-FMT, Number and type of side effects: any adverse event (of any grade according to the CTCAE) that may be linked to FMT must be reported, in particular abdominal pain, transit disorders and bacterial translocations from the day of FMT until 6 months post FMT, Analysis of the fecal microbiota of patients at inclusion and at the 12th week post FMT by sequencin

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026