A Phase 2 interventional study of PH Gastrilex and Placebo Comparator in Inflammatory Bowel Disease, Crohn Disease, sponsored by Soroka University Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Soroka University Medical Center · Phase 2, Interventional, and Treatment
This Phase 2 study aims to evaluate the safety, tolerability, and efficacy of pH Gastrilex™, an enteric-coated capsule formulation containing amorphous calcium carbonate (ACC), in adults with moderate-to-severe Crohn's disease.
This study aims to evaluate the safety, tolerability, and efficacy of pH Gastrilex™, an enteric-coated capsule formulation containing amorphous calcium carbonate (ACC), manufactured by Amorphical Ltd., Israel, in adults with moderate-to-severe Crohn's disease.
Crohn's disease is a chronic, relapsing inflammatory bowel disease associated with intestinal inflammation and impaired epithelial barrier function. The therapeutic rationale for pH Gastrilex™ is based on the hypothesis that local intestinal acidification may contribute to inflammation. The formulation is designed for intestinal release of ACC, whose carbonate component is proposed to buffer the local intestinal acidity through its acid-neutralizing capacity.
This is a single-center, Phase 2, randomized, double-blind, placebo-controlled, parallel-group study evaluates the safety, tolerability, and efficacy of PH Gastrilex™ in adults with moderate-to-severe Crohn's disease (CDAI≥220). Participants are randomized in a 1:1 ratio to receive PH Gastrilex™ or matching placebo for 12 weeks, in addition to best available treatment (BAT).
Following the initial 12-week double-blind phase, participants receiving placebo switch to pH Gastrilex™, while those initially assigned to active treatment continue with pH Gastrilex™ for an additional 12 weeks. Participants completing Week 24 are offered the option to continue treatment with pH Gastrilex™ for a further 48 weeks in an open-label extension, through Week 72.
Clinical assessments include disease activity measured by the Crohn's Disease Activity Index (CDAI), endoscopic evaluation by colonoscopy, and health-related quality of life assessed using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Inflammatory markers, including C-reactive protein (CRP) and fecal calprotectin, are also assessed during the study. Safety and tolerability are assessed through adverse event monitoring, clinical examinations, and laboratory evaluations.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's enrollment of 23 is below the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Soroka University Medical Center is the lead sponsor of 160 studies on the registry; 2 are open to participants now.
Compared within Crohn Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammatory Bowel Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Subject who is taking oral :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PH Gastrilex™ (Amorphous Calcium Carbonate)
Drug: PH Gastrilex
Placebo Followed by PH Gastrilex™ (Amorphous Calcium Carbonate)
Drug: Placebo Comparator
Enteric-coated capsules containing amorphous calcium carbonate (ACC), administered as 2 capsules four times daily (200 mg elemental calcium per capsule; 1,600 mg/day). Weeks 1-12: pH Gastrilex™ + BAT. Weeks 12-24: Continue pH Gastrilex™ + BAT. Weeks 24-72: Optional extension: continue pH Gastrilex™ + BAT.
Also known as: Amorphous calcium carbonate
Matching placebo capsules for the first 12 weeks, followed by PH Gastrilex™ at the same dosing regimen (2 capsules four times daily; 1,600 mg elemental calcium/day). Weeks 1-12: Placebo + BAT. Weeks 12-24: Switch to pH Gastrilex™ + BAT. Weeks 24-72: Optional extension: continue pH Gastrilex™ + BAT.
Change From Baseline in Crohn's Disease Activity Index (CDAI)
Change in CDAI score from baseline to Week 12. The Crohn's Disease Activity Index (CDAI) is a composite score assessing Crohn's disease activity based on clinical and patient-reported parameters
Time frame: Baseline and 12 weeks
Change From Baseline in Crohn's Disease Activity Index (CDAI)
Change in CDAI score from baseline to Week 24. The Crohn's Disease Activity Index (CDAI) is a composite score assessing Crohn's disease activity based on clinical and patient-reported parameters
Time frame: Baseline and 24 weeks
Percentage of participants achieving clinical remission Clinical Remission
The percentage of participants achieving clinical remission, defined as Crohn's Disease Activity Index (CDAI) ≤150.
Time frame: Baseline, Week 12, Week 24, and Week 72
Percentage of participants achieving clinical response
The percentage of participants with a reduction in CDAI of at least 100 points from baseline.
Time frame: Baseline, Week 12, Week 24, and Week 72
Change From Baseline in Stool Frequency
Change from baseline in the mean daily number of liquid or very soft stools, as assessed by the CDAI over a 7-day period
Time frame: Baseline, Week 12, Week 24, and Week 72
Change From Baseline in Abdominal Pain Score
Change in the CDAI abdominal pain component, assessed daily on a 4-point scale (0 = none; 1 = mild; 2 = moderate; 3 = severe).
Time frame: Baseline, Week 12, Week 24, and Week 72
Endoscopic Response
Achieving a ≥50% reduction from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD).
Time frame: Baseline, Week 24, and Week 72
Change From Baseline in Quality of Life (SIBDQ)
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score (range 10-70; higher scores indicate better quality of life).
Time frame: Baseline, Week 12, Week 24, and Week 72
Long-Term Maintenance of Clinical Remission
Percentage of participants maintaining clinical remission (CDAI≤150) during the open-label extension.
Time frame: Week 24 through Week 72
Long-Term Maintenance of Clinical Response
Percentage of participants maintaining clinical response, defined as a reduction in CDAI score of at least 100 points from baseline, during the open-label extension.
Time frame: Week 24 through Week 72
C-Reactive Protein (CRP) Normalization
Percentage of participants achieving CRP levels ≤0.5 mg/dL.
Time frame: Baseline, Week 12, Week 24, and Week 72
Fecal Calprotectin ≤250 µg/g
Percentage of participants achieving fecal calprotectin levels ≤250 µg/g.
Time frame: Baseline, Week 12, Week 24, and Week 72
Plan to share: No — There is currently no established plan to share de-identified individual participant data with external researchers. This statement may be updated if a data-sharing plan is developed.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Amorphous Calcium Carbonate
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