Product Safety & Toxicology

Class IIb medical device Tests: cytotox., sensitization, irritation, subchronic, genotox.

  1. Research question: Is PMA-Zeolith® safe for long-term use in humans?
  2. Method: Physicochemical material characterization (e.g., pH/temperature stability, clinoptilolite content >80%), plus toxicology tests incl. genotoxicity.
  3. Result: No cytotoxicity, no sensitization/irritation, safe subchronic use even at multiples of the recommended dose, no mutagenicity. 2018 review confirms safe use of the specific PMA-Zeolith®.
  4. Conclusion: Based on tests and expert opinions, PMA-Zeolith® can be classified as safe.

Source: Professional information “Research PMA-Zeolith®” (Safety/Toxicology study summary).

Strengthening the intestinal barrier (gold standard study)

RCT, double-blind, placebo-controlled 52 endurance-trained adults 12 weeks · approx. 2 g/day

  1. Research question: Does PMA-Zeolith® affect exercise-induced leaky gut (zonulin, inflammation, performance)?
  2. Method: RCT (Green Beat/MedUni Graz), measuring zonulin (stool), IL-10, etc. at baseline and after 12 weeks.
  3. Result: Significant reduction in zonulin in the treatment group (p<0.05); trend toward increased IL-10 (p<0.1). Suggests improved barrier integrity.
  4. Conclusion: Main outcome: stronger gut barrier; anti-inflammatory tendency.

Source: Lamprecht study (clinical gold standard).

Selective binding of heavy metals & ammonium (in vitro)

Model: stomach/intestine environment (pH) PMA-Zeolith® up to 3 g

  1. Research question: Which harmful substances are bound in the GI tract?
  2. Method: Test solutions with lead, cadmium, arsenic, chromium, nickel, and ammonium; measurement after adding PMA-Zeolith®.
  3. Result: Optimal lead binding in the stomach model; binding of lead, cadmium, arsenic, chromium, nickel in the intestinal model. Ammonium reduction dose-dependent, ~60% at 3 g.
  4. Conclusion: Selective physical binding in the GI tract, potentially protective.

Source: In vitro evidence for cation exchange / ammonium binding.

Irritable Bowel Syndrome (IBS) – pilot study (RCT)

double-blind, placebo 41 IBS patients 2×/day 3 g · 3 months

  1. Research question: Does PMA-Zeolith® reduce subclinical inflammation/barrier dysfunction in IBS?
  2. Method: Blood/stool parameters (hsCRP, zonulin, α1-antitrypsin, IL-10) + microbiome.
  3. Result: Significantly improved α1-antitrypsin (p=0.037) vs. placebo; parallel shifts in Bifidobacterium/Lactobacillus.
  4. Conclusion: Indications of reduced inflammation and improved mucosal integrity.

Source: IBS pilot study (Neuro Endocrinol Lett.).

Irritable Bowel Syndrome – Austria-wide NIS (real-world conditions)

n=204 · 8 weeks 2× daily measuring spoon

  1. Research question: Tolerability & efficacy in IBS under real-life conditions (SF-36, ROM-III, Bristol).
  2. Method: Web diary, before/after questionnaires; subtypes IBS-D/IBS-C/IBS-M.
  3. Result: 7/8 SF-36 subscales improved (p<.001); abdominal pain/bloating decreased; stool consistency normalized – especially in IBS-D (p<.001).
  4. Conclusion: Adjunct option for relieving overall IBS symptoms and improving quality of life.

Source: IBS NIS (Zeitschrift für Gastroenterologie, Preprint 2024).

Osteoporosis – randomized, double-blind, placebo-controlled study (12 months)

n=100 (94f/6m) 3× daily 3 g

  1. Research question: Does PMA-Zeolith® affect bone metabolism and BMD?
  2. Method: BMD, osteocalcin (formation), β-crosslaps (resorption), pain (VAS), QoL.
  3. Result: BMD↑ (p<.001), osteocalcin↑ (p=0.001), β-crosslaps↓ (p=0.027); pain↓, QoL↑ vs. placebo.
  4. Conclusion: Positive effects on bone parameters – plausibly via gut barrier/inflammation modulation.

Source: TOP study (Experimental Biology & Medicine).

Osteoporosis – 5-year follow-up

n=55 (follow-up) Long-term intake

  1. Research question: Long-term effects on bone quality, fractures, pain/QoL.
  2. Method: After 1 year RCT, all received PMA-Zeolith® (total 4–5 years). Parameters: osteocalcin, β-crosslaps, BMD, fractures, VAS.
  3. Result: Osteocalcin↑ & β-crosslaps↓ (p<.05) → preferred bone formation; BMD stable long-term; fractures significantly↓ (p=0.002); pain↓ & overall health↑ (p<.001).
  4. Conclusion: Evidence for balanced bone remodeling and better quality of life over 5 years.

Source: TOP cohort follow-up (Frontiers in Medicine 2022).

Adjunct in oxaliplatin chemotherapy – RCT

n=120 (CRC) 2× 3 g/day · 7 months

  1. Research question: Does PMA-Zeolith® reduce CIPN and improve protocol adherence?
  2. Method: Double-blind RCT; endpoints: CIPN, hematological toxicity, hepatotoxicity, NCS, therapy cycles.
  3. Result: In the male subgroup: significantly less CIPN (p=0.047); 21% more patients with >8 cycles (p=0.03); trend: less severe hematological tox.
  4. Conclusion: Better tolerability/adherence possible; no evidence of reduced chemo efficacy.

Source: ZeOxaNMulti RCT (AORN Cardarelli, 2020).

Chemo follow-up: survival (OS) & progression (PFS)

n=104 (follow-up) Observation time ~30 months

  1. Research question: Does PMA-Zeolith® co-administration affect survival/progression?
  2. Method: DFS/PFS/OS analysis from intervention start; first-line subgroup.
  3. Result: Trend toward improved overall survival overall (p=0.1); after 7 months significantly better OS in first-line (p=0.004); PFS borderline better (p=0.05).
  4. Conclusion: Data support oncological adjuvance; further research warranted.

Source: Survival analyses follow-up (Frontiers in Pharmacology 2022).

Selected blood and mineral parameters

Short-/medium-/long-term protocols ICP-MS & standard methods

  1. Research question: Does PMA-Zeolith® affect relevant mineral/toxin levels in plasma?
  2. Method: 3 study cohorts (28 days; 12 weeks Crohn’s disease; 4 years osteoporosis) with matching placebo/treatment arms.
  3. Result: Overall no undesired demineralization detected; profiles remained within physiological range in treatment groups.
  4. Conclusion: Clinically plausible safe mineral balance under PMA-Zeolith®.

Source: Clinical blood parameter analysis (Frontiers in Medicine 2022).

Studies at a glance

AreaDesign/CohortDuration/DoseKey outcome
SafetyMaterial/tox tests—No tox./geno. risk detected
Gut barrierRCT, n=5212 wk · ~2 g/dayZonulin↓ (p<.05), IL-10 trend
Toxin bindingin vitro—Heavy metals & ammonium bound
IBS pilotRCT, n=413 mo · 2×3 gα1-antitrypsin↓ (p=.037)
IBS NISNIS, n=2048 wkQoL↑; stool/pain improved
OsteoporosisRCT, n=10012 mo · 3×3 gBMD↑; markers improved
OsteoporosisFollow-up, n=555 yrFractures↓ (p=.002); pain↓
ChemoRCT, n=1207 mo · 2×3 gCIPN↓ (men); +21% >8 cycles
ChemoFollow-up, n=104~30 moOS in first-line↑ (p=.004)
Blood parameters3 cohorts28 days–4 yrMineral balance stable
Summary of key parameters/outcomes. Sources: Professional information Research PMA-Zeolith®.

Detailed information on the studies and sources in the PANACEO professional information:

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