Phase 2 Study of pH Gastrilex™ (Enteric-Coated Amorphous Calcium Carbonate Capsules) in Moderate-to-Severe Crohn's Disease
Inflammatory Bowel Disease, Crohn Disease
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 2
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 23 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
1. Signed informed consent form.
2. Men and women, age 18 years and older.
3. Moderate to severe CD patients. Moderately active disease will be defined by a CDAI score between 220 to 450, and severe disease for CDAI score greater than 450.
Exclusion Criteria:
1. Participation in a clinical trial with, or use of, any investigational agent within 30 days or 5 half-lives, whichever is longer, before starting treatment in the trial.
2. Subject who is taking oral corticosteroids:
* Budesonide \>9mg/day
* Prednisone or equivalent\> 20 mg/day
* Or has not been on a current course for\>14 days prior to colonoscopy
3. Subjects who received an approved biological agent less than 16 weeks prior screening.
4. Women patients who are pregnant or breastfeeding. Women patients must have a negative urine or serum test at screening and a negative urine pregnancy test (minimum sensitivity 25IU/L or equivalent units of human chorionic gonadotropin \[hCG\] at baseline, within 24 hours prior to the start of any investigational agent). Male patients with female sexual partners who are pregnant.
5. Hypoparathyroidism.
6. Subjects whose treatment dose has not been stable for at least 14 days before Baseline, or who discontinued treatment within 14 days before Baseline.
7. Other significant medical conditions that may require intervention during the trial.
8. Subjects with consistent hypercalcemia or hypercalciuria.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Quadruple masked
PH Gastrilex™
PH Gastrilex™ (Amorphous Calcium Carbonate)
Drug: PH Gastrilex
Placebo group
Placebo Followed by PH Gastrilex™ (Amorphous Calcium Carbonate)
Drug: Placebo Comparator
PH Gastrilex DRUG
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.
Placebo Comparator DRUG
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Change From Baseline in Crohn's Disease Activity Index (CDAI)
Time frame: Baseline and 12 weeks
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
Change From Baseline in Crohn's Disease Activity Index (CDAI)
Time frame: Baseline and 24 weeks
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
Secondary measures
Percentage of participants achieving clinical remission Clinical Remission
Time frame: Baseline, Week 12, Week 24, and Week 72
The percentage of participants achieving clinical remission, defined as Crohn's Disease Activity Index (CDAI) ≤150.
Percentage of participants achieving clinical response
Time frame: Baseline, Week 12, Week 24, and Week 72
The percentage of participants with a reduction in CDAI of at least 100 points from baseline.
Change From Baseline in Stool Frequency
Time frame: Baseline, Week 12, Week 24, and Week 72
Change from baseline in the mean daily number of liquid or very soft stools, as assessed by the CDAI over a 7-day period
Change From Baseline in Abdominal Pain Score
Time frame: Baseline, Week 12, Week 24, and Week 72
Change in the CDAI abdominal pain component, assessed daily on a 4-point scale (0 = none; 1 = mild; 2 = moderate; 3 = severe).
Endoscopic Response
Time frame: Baseline, Week 24, and Week 72
Achieving a ≥50% reduction from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD).
Change From Baseline in Quality of Life (SIBDQ)
Time frame: Baseline, Week 12, Week 24, and Week 72
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score (range 10-70; higher scores indicate better quality of life).
Long-Term Maintenance of Clinical Remission
Time frame: Week 24 through Week 72
Percentage of participants maintaining clinical remission (CDAI≤150) during the open-label extension.
Long-Term Maintenance of Clinical Response
Time frame: Week 24 through Week 72
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.
C-Reactive Protein (CRP) Normalization
Time frame: Baseline, Week 12, Week 24, and Week 72
Percentage of participants achieving CRP levels ≤0.5 mg/dL.
Fecal Calprotectin ≤250 µg/g
Time frame: Baseline, Week 12, Week 24, and Week 72
Percentage of participants achieving fecal calprotectin levels ≤250 µg/g.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Soroka University Medical CenterBeersheba, South, IsraelStatus unknown
Study team and timeline
- Lead sponsor
- Soroka University Medical Center
- Study start
- Jun 11, 2023 Actual
- Primary completion
- Dec 6, 2025 Actual
- Study completion
- Feb 19, 2026 Actual
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Prospective, Randomized, Parallel, Double Blind, Placebo-Controlled Study, Followed by an Open Label Extension, to Assess the Safety, Tolerability, and Efficacy of pH Gastrilex™ (Enteric-Coated Capsules Containing Amorphous Calcium Carbonate) Administered Concomitantly With Best Available Treatment (BAT) in the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026