DESIGN: Prospective case series, Proof of concept pilot study.
SETTING: Tertiary Health Care Center, Hospital Tuanku Jaafar, Seremban, Malaysia. Department of Surgery.
PARTICIPANTS: A total of 17 patients diagnosed with advanced COJ tumour and who had never undergone any surgical, endoscopic, or chemoradiotherapy and indicated for stenting were recruited.
INTERVENTIONS: The study period was over nine months, and follow-up was one-month post-stenting.
MAIN OUTCOME MEASURES: Endpoint measures were feasibility of deployment of the new design, symptoms relief, early stent migration, early complication, GERD Q score, and (QOL)assessment.
RESULTS: The ART stent was inserted successfully in all cases (17/17, 100%). There were two stent migrations due to the flexibility of the stent at the neck. There were no early or post-stenting one-month complications associated with the procedure. A good flow of contrast was seen in all the stents deployed. GERD Q score was low in all patients pre and post-stenting. Post-stenting there was a relief of dysphagia, weight gain, and a 60% improvement in QOL score.
CONCLUSIONS: ART stent is feasible and technically successful in COJ tumours. It provides good symptom relief, improves the QOL, and has minimal early complications.
FUNDING: None declared.
METHODS: Over 14 days, 60 adults followed protocol requirements, completed food diaries and study questionnaires, avoided consuming supplements with prebiotics, probiotics or postbiotics, and ingested food containing 5 g of total daily fibre [placebo (10.75 g), GBP (10.75 g) or PFP (7.41 g)]. Participants' medical and baseline wellness histories, as well as stool samples, were collected at baseline, day 7 and 14. Stool DNA was processed for sequencing.
RESULTS: Dietary fibre and resistant starches (RS) in GBP and PFP promoted temporal increases in beneficial bacteria. GBP significantly elevated 7 species (F. prausnitzii, B. longum, B. bifidum, B. adolescentis, B. pseudocatenulatum, B. obeum, and R. inulinivorans), while PFP enriched 6 species (B. ovatus, B. cellulosilyticus, B. bifidum, B. intestinalis, R. inulinivorans, and E. siraeum). These bacteria, found to be deficient in younger adults, were promoted by both powders. PFP benefitted both genders aged 16-23, while GBP benefitted overweight/obese individuals, including females. GBP and PFP fiber and RS improved bowel regularity and health as well as metabolism by promoting histidine, branched-chain amino acids, short-chain fatty acids, and biotin production. The additional fiber caused "low" bloatedness and reduced "fairly bad" sleep disruptions, without affecting sleep durations.
CONCLUSION: GBP and PFP supplementation increased beneficial bacteria and metabolites, improved host gut health, and present a valuable nutritional strategy for enhancing human health.
CLINICAL TRIAL REGISTRATION: AMILI Institutional Review Board, Identifier 2023/0301.