{"doi":"10.3389/fmed.2021.782859","title":"Butanol Purified Food Allergy Herbal Formula-2 Has an Immunomodulating Effect ex-vivo in Pediatric Crohn's Disease Subjects","abstract":"Background: TNF-α has a major role in the pathogenesis of Crohn's disease (CD). In contrast, GM-CSF may be beneficial for its anti-inflammatory role in a subset of patients with CD with antibodies against GM-CSF as seen in prior trials of GM-CSF which resulted in clinical improvement in CD. We developed butanol purified Food Allergy Herbal Formula-2 (B-FAHF-2) by refining FAHF-2. FAHF-2 suppressed TNF-α production by human peripheral blood mononuclear cells (PBMCs) and colonic mucosa, and abrogated colitis in a murine model. We sought to examine the effect of B-FAHF-2 and the herbs that comprise it on TNF-α and GM-CSF production as a potential herbal therapy for the treatment of CD. Methods: B-FAHF-2 was examined using high pressure liquid chromatography (HPLC) and compared to the original formulation, FAHF-2. PBMCs from pediatric patients with CD were cultured with lipopolysaccharide and B-FAHF-2, individual herbs or medium alone. Colonic biopsy specimens were cultured with or without B-FAHF-2. TNF-α and GM-CSF were measured by enzyme-linked immunosorbent assay (ELISA). B-FAHF-2 efficacy was tested in vivo in the CD45Rb hi transfer model. Results: B-FAHF-2 had a similar HPLC fingerprint as FAHF-2 but decreased TNF-α production by PBMCs and colonic mucosa from pediatric CD subjects at 20% of the FAHF-2 dose. B-FAHF-2 increased GM-CSF production by PBMCs and colonic mucosa from pediatric CD subjects including those with antibodies to GM-CSF. Of B-FAHF-2's herbal constituents, only Huang Bai suppressed TNF-α and increased GM-CSF production. In the murine model, B-FAHF-2 treatment alleviated colitis. Conclusions: B-FAHF-2 decreased TNF-α production by PBMCs and colonic mucosa from pediatric subjects at a lower dose than FAHF-2. B-FAHF-2 also increased GM-CSF production by PBMCs independent of antibodies. B-FAHF-2 may have a benefit in CD patients.","journal":"Frontiers in Medicine","year":2021,"id":205458,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":2,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.952,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2021-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":788769,"name":"Joanne Lai","orcid":"0000-0003-0974-8210","position":1,"is_corresponding":false},{"id":766017,"name":"Ying Song","orcid":"0000-0002-2814-6525","position":2,"is_corresponding":false},{"id":788770,"name":"Nan Yang","orcid":"0000-0002-1610-5240","position":3,"is_corresponding":false},{"id":104270,"name":"Sacha Gnjatic","orcid":"0000-0001-5643-9520","position":4,"is_corresponding":false},{"id":569671,"name":"Virginia Gillespie","orcid":"0000-0003-3387-0021","position":5,"is_corresponding":false},{"id":789215,"name":"William V. Hahn","orcid":null,"position":6,"is_corresponding":false},{"id":789216,"name":"Ezra Chefitz","orcid":null,"position":7,"is_corresponding":false},{"id":677497,"name":"Nanci Pittman","orcid":null,"position":8,"is_corresponding":false},{"id":789217,"name":"Jacqueline Jossen","orcid":null,"position":9,"is_corresponding":false},{"id":460941,"name":"Keith Benkov","orcid":"0000-0003-3232-7705","position":10,"is_corresponding":false},{"id":487559,"name":"Marla Dubinsky","orcid":null,"position":11,"is_corresponding":false},{"id":766026,"name":"Xiu-Min Li","orcid":"0000-0002-5296-2960","position":12,"is_corresponding":false},{"id":265882,"name":"David Dunkin","orcid":"0000-0002-7921-134X","position":13,"is_corresponding":false},{"id":418267,"name":"Qingrong Chen","orcid":"0000-0003-1325-6147","position":0,"is_corresponding":true}],"reference_count":25,"raw_metadata":null,"created_at":"2026-07-18T23:51:33.996102Z","pmid":"34926527","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}