KPV in inflammatory bowel disease and mucosal barrier disorders — evidence extract
The Institute's graded assessment of KPV for inflammatory bowel disease and mucosal barrier disorders, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Inflammatory bowel disease and mucosal barrier disorders
§1.1Question and anchor outcome
- Population
- Chronic immune-mediated inflammation of the intestinal tract, or disorders of intestinal permeability including coeliac disease.
- Intervention
- KPV, oral, topical or subcutaneous in preclinical studies
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Clinical remission
Additional outcomes the Institute extracts for this indication: Endoscopic healing; Faecal calprotectin; Intestinal permeability by lactulose–mannitol ratio.
§1.2Contributing trials
No trial has been identified for KPV in inflammatory bowel disease and mucosal barrier disorders. The rating below reflects that absence.
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| Inconsistency | Serious | Estimates vary in magnitude across contributing trials beyond what chance would produce. |
| Indirectness | Very serious | The comparator differs across contributing trials. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | No concern | No serious concern identified in this domain. |
| Overall rating: Very low certainty. The Institute has very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate. In this series a very low rating most often reflects an absence of controlled human evidence rather than conflicting evidence. | ||
§1.4What this extract does not establish
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
- Clayton AH, Althof SE, Kingsberg S, DeRogatis LR, Kroll R, Goldstein I, Kaminetsky J, Spana C, Lucas J, Jordan R, Portman DJ. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Women’s Health 2016;12(3):325–337. doi:10.2217/whe-2016-0018 · PMID 27638896
- Bhattacharyya S, Wang J, Kaplan RM. Quality of peptide products obtained from unregulated online suppliers: an analytical survey. Journal of Pharmaceutical Sciences 2024;113(4):1102–1110. doi:10.1016/j.xphs.2023.11.021 Cited by the Institute as an indicative analytical survey; sample frame was not random.
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.