MHS-1031 for Acid Reflux

Recruiting at 11 trial locations

Overseen By Salma Saiger, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Microbiome Health Sciences

Must be taking: PPIs

Must not be taking: H2RAs, Antidepressants, NSAIDs, others

Disqualifiers: Cancer, Heart disease, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

156 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will be conducted as a multi-center, randomized, double-blind, placebo-controlled trial to evaluate the effect of MHS-1031 on heartburn-free days in subjects with GERD-related heartburn symptoms.

Do I need to stop taking my current medications for the trial?

The trial requires that you stay on stable doses of medications prescribed for chronic conditions other than GERD. If you are taking certain medications like histamine 2 receptor antagonists, you will need to stop them with a 7-day washout period before starting the trial. Please check with the trial team for specific guidance on your medications.

What evidence supports the effectiveness of the treatment MHS-1031 for acid reflux?

Research shows that a similar soluble fiber, maltosyl-isomaltooligosaccharide, improved symptoms in 88% of GERD patients, suggesting that MHS-1031, which includes Panosyl-Isomaltooligosaccharides, might also help with acid reflux. ^{1 2 3 4 5}

How does the treatment MHS-1031 for acid reflux differ from other treatments?

MHS-1031 may involve the use of prebiotic sugarcane flour, which has shown significant positive effects in reducing symptoms of acid reflux, such as heartburn and regurgitation, in a pilot study. This treatment is unique because it uses a natural ingredient with prebiotic properties, unlike traditional antacids or proton pump inhibitors. ^{1 6 7 8 9}

Research Team

Peter Swann, MD

Principal Investigator

Microbiome Health Sciences

Eligibility Criteria

Adults aged 18-75 with a BMI of 19-35, experiencing GERD-related heartburn despite taking daily PPI medication, can join this trial. They must be able to complete online questionnaires in English and have had an endoscopy within the last 90 days. Women should use contraception if of childbearing potential. Exclusions include recent stroke or MI, GI abnormalities affecting motility, certain dietary supplements like FOS or inulin, rigorous weight loss programs, neuropsychiatric disorders, gastric surgery history except benign polyp removal.

Inclusion Criteria

Are you between the age of 18-75?

Are you within 30 miles from Atlanta, or be willing/able to travel to Atlanta GA to attend 4 onsite appointments?

Have you been diagnosed with Gastroesophageal Reflux Disease (GERD)?

Exclusion Criteria

In the last year have you struggled with alcoholism or frequent tobacco or nicotine use?

Timeline

Remote Screening Phase 2-Week Assessment (SP1)

Participants are screened for eligibility to participate in the trial

2 weeks

Remote assessment

On-site Screening Phase Part 2 (SP2)

Participants undergo further screening to confirm eligibility

1-2 weeks

1 visit (in-person)

Treatment Phase

Participants receive either Panosyl-isomaltooligosaccharide or placebo adjunctive to PPI therapy

8 weeks

Weekly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MHS-1031
• Placebo

Trial Overview The study tests MHS-1031's effectiveness on increasing heartburn-free days for GERD patients compared to a placebo. Participants will be randomly assigned to either receive MHS-1031 or a placebo without knowing which one they're getting (double-blind). They'll continue their usual PPI therapy throughout the trial.

Participant Groups

Group I: Drug Product Active Control 1 Intervention

Panosyl-isomaltooligosaccharide (PIMO) liquid 1 g (1.5 ml) per day for 8 weeks

Group II: Placebo Placebo Group 1 Intervention

Placebo liquid (1.5 ml) per day for 8 weeks

Who Is Running the Clinical Trial?

Microbiome Health Sciences

Lead Sponsor

Trials

3

Recruited

540+

VBHRC Virginia Catalyst

Collaborator

Trials

1

Recruited

160+

Findings from Research

In a pilot study involving 43 participants with medically-diagnosed GERD, prebiotic sugarcane flour significantly reduced symptoms like heartburn and regurgitation compared to a placebo after three weeks of treatment.

The study found that the intervention group experienced a mean decrease in heartburn symptoms by 2.2 points and total symptom scores by 3.7 points, indicating that sugarcane flour may be an effective dietary intervention for managing GERD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-Heartburn Effects of Sugar Cane Flour: A Double-Blind, Randomized, Placebo-Controlled Study. Beckett, JM., Singh, NK., Phillips, J., et al.[2021]

Feeding Balb/c mice fermented milk containing EPS-producing S. thermophilus CRL 1190 for 7 days significantly reduced gastric inflammation and preserved gastric mucosa structure compared to untreated gastritis mice, indicating its potential therapeutic effect.

The treatment led to a decrease in pro-inflammatory cytokines (INFgamma and TNF-alpha) and an increase in the anti-inflammatory cytokine IL-10, along with a thicker mucus layer, suggesting a mechanism of action that enhances gastric protection and reduces inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effect of Streptococcus thermophilus CRL 1190-fermented milk on chronic gastritis. Rodríguez, C., Medici, M., Mozzi, F., et al.[2021]

In a study of 24 patients with gastroesophageal reflux disease (GERD), 88% experienced symptom improvement after consuming a specific prebiotic soluble fiber called maltosyl-isomaltooligosaccharide (MIMO) for several weeks.

Notably, two patients who were dependent on proton pump inhibitors (PPIs) were able to eliminate their PPI therapy after starting MIMO, marking the first reported instance of a prebiotic fiber improving GERD symptoms and reducing reliance on PPIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in Gastroesophageal Reflux Symptoms From a Food-grade Maltosyl-isomaltooligosaccharide Soluble Fiber Supplement: A Case Series. Selling, J., Swann, P., Madsen, LR., et al.[2020]

In a study involving 9 patients with gastroesophageal reflux disease (GERD), the administration of fructooligosaccharides (FOS) significantly increased the number of transient lower esophageal sphincter relaxations (TLESRs) and reflux episodes compared to a placebo, worsening GERD symptoms.

The increase in reflux and symptoms was associated with a higher plasma response of glucagon-like peptide 1 (GLP-1) after FOS intake, suggesting that colonic fermentation of carbohydrates may exacerbate GERD through mechanisms involving GLP-1 release.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colonic fermentation influences lower esophageal sphincter function in gastroesophageal reflux disease. Piche, T., des Varannes, SB., Sacher-Huvelin, S., et al.[2022]

The newly identified pentasaccharide, LA-EPS-20079, derived from Lactobacillus acidophilus DSMZ 20079, demonstrated significant tumor-suppressive effects against human colon cancer cells (CaCo-2), achieving an 80.65% reduction in cell viability at non-toxic doses.

LA-EPS-20079 was found to selectively target cancer cells while being safe for normal mammalian cells, with a selectivity index ranging from 1.96 to 51.3, and it also up-regulated key genes involved in apoptosis and inflammation, indicating its potential as a therapeutic agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel purified Lactobacillus acidophilus 20079 exopolysaccharide, LA-EPS-20079, molecularly regulates both apoptotic and NF-κB inflammatory pathways in human colon cancer. El-Deeb, NM., Yassin, AM., Al-Madboly, LA., et al.[2022]

In a study of 53 patients with symptomatic reflux oesophagitis, both dimethicone/antacid (Asilone Gel) and alginate/antacid (Gaviscon liquid) significantly improved symptoms like heartburn and acid regurgitation over an 8-week period.

Dimethicone/antacid showed a significant advantage in improving histological changes in the esophagus, suggesting it may be more effective in treating the underlying inflammation compared to alginate/antacid, although both treatments were similarly effective for symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a dimethicone/antacid (Asilone gel) with an alginate/antacid (Gaviscon liquid) in the management of reflux oesophagitis. Smart, HL., Atkinson, M.[2022]

In a double-blind study involving 32 patients with chronic heartburn, both liquid antacid and placebo showed significant improvements in the frequency and severity of heartburn, indicating that the natural history of reflux esophagitis tends to improve over time regardless of treatment.

There was no significant difference in the effectiveness of antacid compared to placebo in healing esophagitis or reducing painful episodes, suggesting that the perceived benefits of antacids may be due to a placebo effect rather than a direct therapeutic action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind comparison of liquid antacid and placebo in the treatment of symptomatic reflux esophagitis. Graham, DY., Patterson, DJ.[2019]

In a study involving 1107 participants with mild-to-moderate GERD, Gaviscon Double Action (DA) was found to be significantly more effective than a placebo in reducing symptoms of heartburn, regurgitation, and dyspepsia, with notable improvements in Reflux Disease Questionnaire scores.

The treatment was safe, showing a similar incidence of adverse events compared to the placebo group, indicating that Gaviscon DA can be a reliable option for managing GERD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised clinical trial: the clinical efficacy and safety of an alginate-antacid (Gaviscon Double Action) versus placebo, for decreasing upper gastrointestinal symptoms in symptomatic gastroesophageal reflux disease (GERD) in China. Sun, J., Yang, C., Zhao, H., et al.[2018]

In a study of 214 patients with non-erosive gastro-oesophageal reflux disease (GERD), lansoprazole significantly reduced daytime and night-time heartburn compared to placebo, showing effectiveness from the first day of treatment.

Patients taking lansoprazole experienced fewer days and nights with heartburn and less need for antacids over the 8-week treatment period, with a similar safety profile to the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lansoprazole in the treatment of heartburn in patients without erosive oesophagitis. Richter, JE., Kovacs, TO., Greski-Rose, PA., et al.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Anti-Heartburn Effects of Sugar Cane Flour: A Double-Blind, Randomized, Placebo-Controlled Study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Therapeutic effect of Streptococcus thermophilus CRL 1190-fermented milk on chronic gastritis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Improvement in Gastroesophageal Reflux Symptoms From a Food-grade Maltosyl-isomaltooligosaccharide Soluble Fiber Supplement: A Case Series. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Colonic fermentation influences lower esophageal sphincter function in gastroesophageal reflux disease. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A novel purified Lactobacillus acidophilus 20079 exopolysaccharide, LA-EPS-20079, molecularly regulates both apoptotic and NF-κB inflammatory pathways in human colon cancer. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Comparison of a dimethicone/antacid (Asilone gel) with an alginate/antacid (Gaviscon liquid) in the management of reflux oesophagitis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Double-blind comparison of liquid antacid and placebo in the treatment of symptomatic reflux esophagitis. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Randomised clinical trial: the clinical efficacy and safety of an alginate-antacid (Gaviscon Double Action) versus placebo, for decreasing upper gastrointestinal symptoms in symptomatic gastroesophageal reflux disease (GERD) in China. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Lansoprazole in the treatment of heartburn in patients without erosive oesophagitis. [2019]