Trial reportPloS one2015
Gastrointestinal pH and Transit Time Profiling in Healthy Volunteers Using the IntelliCap System Confirms Ileo-Colonic Release of ColoPulse Tablets.
Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
54 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A Quantitative Review and Meta-models of the Variability and Factors Affecting Oral Drug Absorption-Part II: Gastrointestinal Transit Time.The AAPS journal · 2016Pooled it
- Nonclinical and Clinical Assessments of an Optimized Tablet Formulation of the Novel HER2-Selective Tyrosine Kinase Inhibitor Zongertinib: Focus on Relative Bioavailability and Impact of Variation of Gastric pH.Molecular pharmaceutics · 2025Trial
- Randomised clinical study: inulin short-chain fatty acid esters for targeted delivery of short-chain fatty acids to the human colon.Alimentary pharmacology & therapeutics · 2016Trial
- Unveiling the impact of colonic pH and pH-sensing receptors in blood pressure regulation.Gut microbes · 2026Review
- Bacteriophage Sf14 survival under simulated gastrointestinal conditions.bioRxiv : the preprint server for biology · 2026Article
- Ecological and dietary strategies to constrain Clostridioides difficile.Cell host & microbe · 2026Review
- Multi-region sampling of the human small intestine using an ingestible device.medRxiv : the preprint server for health sciences · 2026Article
- Intrinsically disordered protein coating for oral delivery of peptide drugs.Cell biomaterials · 2026Article
- Contrasting pH optima of β-lactamases CTX-M and CMY influenceApplied and environmental microbiology · 2026Article
- Article
- Fermentation-driven interactions of gut microbes with their environment.Essays in biochemistry · 2025Review
- Proton-pump inhibitors increaseGut microbes · 2025Article
- Hydrogel-based experimental models of the gastrointestinal tract.Microbiome · 2025Review
- Intestinal pH: a major driver of human gut microbiota composition and metabolism.Nature reviews. Gastroenterology & hepatology · 2025Review
- Delving the depths of 'terra incognita' in the human intestine - the small intestinal microbiota.Nature reviews. Gastroenterology & hepatology · 2025Review
- Advances in Colon-targeted Drug Delivery Systems: Innovative Strategies for Treating Colonic Disorders and Prospects for the Future.Current pharmaceutical biotechnology · 2025Review
- The release of GLP-1 from gut L cells is inhibited by low extracellular pH.Obesity (Silver Spring, Md.) · 2024Article
- Synthesis and Characterization of Triticale Starch-Based Hydrogel for pH Responsive Controlled Diffusion.ACS omega · 2024Article
- Biomimetic Exogenous "Tissue Batteries" as Artificial Power Sources for Implantable Bioelectronic Devices Manufacturing.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionColoPulse tablets are an innovative development in the field of oral dosage forms characterized by a distal ileum and colon-specific release. Previous studies in humans showed release in the ileo-colonic region, but the relationship between gastrointestinal pH and release was not experimentally proven in vivo. This information will complete the in vivo release-profile of ColoPulse tablets. MATERIALS AND
methodsRelease from ColoPulse tablets was studied in 16 healthy volunteers using the dual label isotope strategy. To determine gastrointestinal pH profiles and transit times the IntelliCap system was used. A ColoPulse tablet containing 13C-urea and an uncoated, immediate release tablet containing 15N2-urea were taken simultaneously followed by a standardized breakfast after three hours. Five minutes after intake of the tablets the IntelliCap capsule was swallowed and pH was measured until excretion in the feces. Breath and urine samples were collected for isotope analysis.
resultsFull analysis could be performed in 12 subjects. Median bioavailability of 13C -urea was 82% (95% CI 74-94%, range 61-114%). The median lag time (5% release of 13C) was 5:42 h (95% CI 5:18-6:18 h, range 2:36-6:36 h,) There was no statistically significant difference between lag time based on isotope signal and colon arrival time (CAT) based on pH (median 5:42 vs 5:31 h p = 0.903). In all subjects an intestinal pH value of 7.0 was reached before release of 13C from the ColoPulse tablet occurred. DISCUSSION AND
conclusionsFrom the combined data from the IntelliCap system and the 13C -isotope signal it can be concluded that release from a ColoPulse tablet in vivo is not related to transit times but occurs in the ileo-colonic region after pH 7.0 is reached. This supports our earlier findings and confirms that the ColoPulse system is a promising delivery system for targeting the distal ileum and colon.
trial registrationISRCTN Registry 18301880.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.