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Phase 2 Randomized Double‑Blind Placebo‑Controlled Study of MH002 in Adults with Mild‑to‑Moderate Ulcerative Colitis Inadequately Controlled by 5‑ASA

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at people with mild-to-moderate Ulcerative Colitis whose symptoms are not fully controlled with 5-Aminosalicylic Acid. The treatment being tested is an oral capsule containing the probiotic‑like product MH002 given in two possible strengths, compared with a matching placebo. The capsule is taken by mouth once daily.

The purpose of the study is to confirm that MH002 can reduce disease activity. Participants will be randomly assigned to one of the three groups, will not know which they receive, and will be followed for about three months. During this time they will have regular visits for a colon camera exam (used to calculate the Mayo endoscopic subscore), stool tests for fecal calprotectin, and will fill out a short symptom questionnaire called PRO-2. Safety will be monitored by checking for side effects and routine lab tests.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline visit and randomization
You attend a clinic appointment where your health status is recorded, including a colon examination and laboratory tests. this information is used as the starting point for the study.
After the baseline measurements, you are assigned by chance to receive either a low dose of mh002 (10,000 million colony forming units per capsule), a high dose of mh002 (40,000 million colony forming units per capsule), or a placebo capsule that looks the same but contains no active ingredient. the assignment is kept secret from you and the study staff.
Step 2
Start taking study medication
You begin taking one oral capsule each day, preferably at the same time each day, for a total of 12 weeks.
If you were assigned the low dose, the capsule contains 10,000 million CFU (colony forming units) of mh002. if you were assigned the high dose, the capsule contains 40,000 million CFU of mh002. if you were assigned the placebo, the capsule contains no active substance.
Step 3
Record daily symptoms
You use an electronic diary to note any symptoms of ulcerative colitis, such as stool frequency, blood in stool, abdominal pain, and overall well‑being. this information helps the study assess how the medication affects your condition.
Step 4
Clinic visit at week 4
You return to the clinic after four weeks of treatment.
The study team checks your vital signs, performs blood tests, and may collect a stool sample to measure fecal calprotectin, a marker of intestinal inflammation.
Any side effects you have experienced are recorded.
Step 5
Clinic visit at week 8
You attend a second follow‑up visit eight weeks after starting the medication.
Similar evaluations are performed as at week 4, including blood work, stool testing, and a review of your diary entries.
Step 6
Final visit at week 12
You complete the 12‑week treatment period and attend the final study visit.
A colon examination is performed to assess the Mayo endoscopic subscore, which measures the severity of inflammation in the colon.
Blood and stool samples are taken again, and the study team evaluates whether you have achieved clinical remission, defined as a low overall disease score and no rectal bleeding.
All adverse events and any laboratory changes are documented.
Step 7
Study completion
After the week 12 assessments, you stop taking the study capsule.
The study team may provide information about any further follow‑up that is recommended for your health, but no additional study medication is given.

Who can join the trial?

11 criteria

Be a male or female who is at least 16 years old (at least 18 years old in the Czech Republic); younger participants may join only if local laws allow.
Have a confirmed diagnosis of ulcerative colitis that was made at least three months before screening, with a biopsy report showing the tissue findings.
Have active mild‑to‑moderate ulcerative colitis at screening, shown by a total score of 4‑7 on the modified Mayo score, an endoscopic score (MES) of 2 or higher, a rectal bleeding score of 1 or 2, and a stool‑frequency score of at least 1. (The modified Mayo score measures overall disease activity; the endoscopic score looks at inflammation seen during a colon exam; the rectal bleeding score measures bleeding; the stool‑frequency score counts bowel movements.)
Have disease areas (lesions) that extend at least 10 cm upward from the anus.
Be taking a stable dose of oral 5‑ASA medication for at least four weeks before randomization and continue the same dose throughout the study, or have not responded to at least 2 g per day of oral 5‑ASA for six weeks, or be unable to tolerate 5‑ASA or be advised not to use it.
Sign a written informed consent form (or assent if under the legal age).
If you are a female who could become pregnant, you must agree to use an acceptable method of contraception for the whole study period, in countries where this is required.
Have completed the week 12 visit of the initial treatment phase, shown good compliance, and finished all required questionnaires.
Agree to follow all study rules, including taking the study drug as instructed, attending all study visits, completing assessments (including using your own device to report data), and providing stool samples.
Have had no major safety problems during the initial treatment phase, as judged by the doctor.
If you are a female of child‑bearing potential, continue to use an acceptable contraceptive method for the entire study, where required.

Who cannot join the trial?

22 criteria

Having a diagnosis of Crohn’s disease (a different type of inflammatory bowel disease), undetermined colitis (colon inflammation with unknown cause), ischemic colitis (colon damage due to reduced blood flow), fulminant colitis (very severe colon inflammation), or toxic megacolon (dangerous swelling of the colon).
Showing an active infection of the stomach or intestines, or any other organ, at the screening visit (unless the infection is judged harmless). This includes a current Clostridium difficile infection that must be treated and have a negative test before screening.
Having very severe ulcerative colitis (UC) as judged by medical scoring systems, ulcerative proctitis only, the most severe disease in the transverse or ascending colon, or planning a hospital stay at the time of screening.
Having had a total removal of the colon (total colectomy), a permanent abdominal opening for waste (stoma), an ileo‑anal pouch surgery, or a major colon surgery that left less than 30 cm of colon.
Having an intra‑abdominal fistula (abnormal connection), an abscess (pocket of infection), diverticulitis (inflamed pouches in the colon), or gastrointestinal bleeding that is not caused by ulcerative colitis.
Having a history of colon cancer or high‑grade dysplasia (precancerous cells in the colon).
Having previously used any advanced ulcerative colitis medicines such as anti‑tumor necrosis factor drugs, anti‑integrin or anti‑interleukin agents, Janus kinase inhibitors, or sphingosine‑1‑phosphate receptor modulators.
Having taken sulfasalazine (a medication for ulcerative colitis) within the four weeks before randomization.
Having taken corticosteroids or disease‑modifying antirheumatic drugs (including thiopurines) within six weeks before randomization, except for a stable low dose of oral prednisone (10 mg or less per day) for at least two weeks before the screening colonoscopy and continuing through week 12.
Having used antibiotics (except for topical use), prebiotics, or probiotics within four weeks before randomization or planning to use them during the study, or using an antidiarrheal drug regularly, or any rectal treatment.
Having received a fecal microbiota transplantation (a stool transplant to change gut bacteria) within the past 52 weeks.
Having been treated with another experimental drug or procedure within 30 days before screening, or within five times the drug’s elimination half‑life (the time it takes for the drug level to drop by half), whichever is longer.
Being in an immunocompromised state (a weakened immune system), such as having active HIV infection, any cancer, severe liver scarring (cirrhosis), or receiving systemic chemotherapy.
Having low blood counts or clotting problems, including white blood cells below 3,000/µL, neutrophils below 1,000/µL, hemoglobin below 10 g/dL, platelets below 100 × 10⁹/L, or any disorder that greatly increases bleeding risk.
Having ongoing or recent (within three months) severe kidney disease or reduced kidney function, shown by a glomerular filtration rate (GFR) of 60 mL/min or lower.
Having ongoing or recent (within three months) advanced liver disease, defined by a Child‑Pugh score of 10 or higher (Class C) or liver blood tests (AST, ALT, bilirubin, prothrombin time, INR) that are at least twice the normal upper limit.
Having a significant bone‑marrow disease that is progressive or uncontrolled, or a history of solid‑organ or bone‑marrow transplantation.
Having any protein‑losing enteropathy (a condition where the gut loses protein), any granulomatous disease (diseases with small inflammatory nodules), or any progressive or uncontrolled systemic autoimmune disease (well‑controlled diabetes is allowed).
Having active intravenous drug abuse (injecting illegal drugs) or an alcohol abuse disorder as judged by the investigator.
Being pregnant or breastfeeding at the time of study entry.
Being considered unsuitable by the investigator for reasons such as having another condition that makes participation unsafe, known allergy to similar medicines or any component of the study drug, unlikely to complete the study, or being unwilling or unable to follow study requirements (taking medication, attending visits, completing questionnaires, etc.).
Being an employee or a close relative of an employee of the investigator, study site, contract research organization, or sponsor.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera di Padova
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Padua, Italy
Azienda Socio Sanitaria Territoriale Ovest Milanese
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Legnano, Italy
EMC Instytut Medyczny S.A.
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Poznan, Poland

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Investigated drugs

MH002 is an oral capsule that contains a large number of live beneficial bacteria, known as a probiotic. In this study, the capsule is being tested to see if it can help reduce the inflammation and symptoms of ulcerative colitis in people whose disease is not fully controlled by standard medication (5‑aminosalicylic acid). Participants take the capsule by mouth, and researchers will compare how well it works and how safe it is at different strengths.

What is already known about the treatment

MH002 - MH002 is taken orally as a capsule that delivers a high number of live bacteria (10‑40 billion CFU) to the gut; it is currently an investigational probiotic being studied in phase 2 trials and is not yet approved for routine medical use. The product is intended to help people with mild‑to‑moderate ulcerative colitis whose symptoms are not fully controlled by standard medication. It works by introducing beneficial microbes that can balance the intestinal flora, reduce inflammation, and strengthen the gut lining at a molecular level through interaction with immune cells and bacterial metabolites. MH002 belongs to the pharmacological class of probiotic live‑microbial preparations.

Investigated diseases

Ulcerative Colitis - Ulcerative colitis is a chronic condition that causes inflammation and sores in the lining of the large intestine. It typically begins in the rectum and can spread upward, involving more of the colon over time. The inflamed lining leads to frequent loose stools, urgency, and sometimes visible blood. As the disease progresses, the affected area may develop larger ulcers that bleed more easily. The pattern often includes periods of worsening symptoms followed by times of fewer complaints.