INGUTSKIN: double-blind RCT protocol on chicory inulin in mild psoriasis — study not yet conducted
This document is a study protocol, not a completed RCT; no efficacy or safety data have been generated to date.
| Outcome | Grade | Direction | Effect | Studies |
|---|---|---|---|---|
| Psoriasis severity (PASI) | D | — Insufficient | not reported (protocol only) | — |
| Fecal microbiota characteristics | D | — Insufficient | not reported (protocol only) | — |
| Intestinal permeability | D | — Insufficient | not reported (protocol only) | — |
| Systemic inflammatory and immune markers | D | — Insufficient | not reported (protocol only) | — |
| Quality of life | D | — Insufficient | not reported (protocol only) | — |
| Body composition | D | — Insufficient | not reported (protocol only) | — |
| Adverse events and compliance | D | — Insufficient | not reported (protocol only) | — |
Context
Psoriasis is associated with intestinal dysbiosis and increased gut permeability, suggesting the gut-skin axis is mechanistically relevant. Inulin-type prebiotics modulate the microbiota and may influence systemic immune responses. The absence of completed RCTs in this specific population justifies the proposed design.
What the study showed
The study has not been conducted; no results are available. The document describes only the planned methodological protocol. No efficacy, safety, or any clinical or laboratory outcome data are reported. Any claim of benefit from inulin in this population is not supported by this manuscript.
How it was done
Double-blind, placebo-controlled RCT protocol with two parallel arms, planned duration of 8 weeks. The target population consists of adults with mild psoriasis recruited in a clinical setting. Sample size and randomisation criteria are described in the protocol, but no data have been collected.
Effect magnitude
Not applicable — no data have been collected or analysed. Effect size, 95% CI, and p-values do not exist at this stage.
Limitations
This is exclusively a protocol; the complete absence of data precludes any risk-of-bias assessment using RoB 2 or ROBINS-I. Restriction to mild psoriasis (PASI < 10) and BMI < 30 will limit future generalisability. Maltodextrin as placebo may have its own metabolic effects, an active comparator bias risk not addressed in the protocol.
In clinical practice
There is no basis for changing clinical practice based on this document. Clinicians should await RCT results before considering ITFs as an adjunct in mild psoriasis. The protocol is useful for understanding which outcomes will be measured and how to interpret future results.
What is still missing
The results of the INGUTSKIN RCT itself are required before any conclusion can be drawn. Subsequent studies should assess moderate-to-severe psoriasis and populations with BMI ≥ 30, which were excluded.