Ulcerative ColitisPhase 1NCT00578799
Effects of Probiotics in Patients With Ulcerative Colitis
A Phase 1 study testing Kyo-Dophilus in people with Ulcerative Colitis, run by University of California, Irvine at 1 site in United States.
Trial summary
This study is being conducted in patients who have been diagnosed with ulcerative colitis (UC), a form of inflammatory bowel disease (IBD) - a disease of the intestine. The purpose of this study is to test the therapeutic (medical treatment) effects of daily consumption of Kyo-Dophilus (a commercially available… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Kyo-Dophilus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We will be studying patients with mild to moderate active ulcerative colitis (UC).
- Patients are eligible to participate if:
- they are between 18 and 65 yr of age;
- have an endoscopic and histologic confirmed diagnosis of UC for at least 1 yr; and
- have at least a 2 week history of active UC that has not responded to mesalamine therapy.
- Subjects will not have consumed any fermented products, such as yogurt, for at least 6 weeks prior to being entered into the trial.
Who cannot join
- Subjects will be excluded if they have the following:
- Crohn's disease,
- disease less than 25 cm from the anal canal,
- active enteric infection,
- evidence of severe disease characterized by hemoglobin <8.0 g/dl, white blood cell count >20,000 cells/mm3, temperature >38.5◦C, albumin <25 g/dl, active disease >2 months, UCDAI < 2 or >9,
- history of dysplasia of the colon or any cancer within 5 years,
- clinically significant hematologic values (see above) or biochemical values (serum creatinine concentrations >1.5 times the upper limit of normal or alkaline phosphatase, aspartate aminotransferase, or alanine aminotransferase concentrations >2.5 times the upper limit of normal) are also ineligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine, Health Sciences Medical Center
Orange, California, 92868
About this study
Official title: Effects of Probiotics in Patients With Ulcerative Colitis.
This study is being conducted in patients who have been diagnosed with ulcerative colitis (UC), a form of inflammatory bowel disease (IBD) - a disease of the intestine.
The purpose of this study is to test the therapeutic (medical treatment) effects of daily consumption of Kyo-Dophilus (a commercially available dietary supplement often used by individuals with inflammatory bowel disease) on their UC. Kyo-Dophilus consists of three probiotic bacteria (beneficial bacteria to help maintain the balance of good bacteria in the intestine) to help treat inflammatory bowel disease caused by bad bacteria. Patients will still be maintained on their clinical standard of care for their UC as part of their participation in this study.
Read the detailed description
Probiotics are defined as "live microorganisms, which, when administered in adequate amounts, confer a health benefit on the host." Most probiotics are lactic acid producing bacteria that are endogenous to the human GI (gastrointestinal) tract and are commonly utilized in the fermentation of food products, such as yogurt. Disturbances in the composition of the bacterial flora of the GI tract are associated with diarrhea and inflammatory bowel disease (IBD), and consumption of some strains of probiotic bacteria are very effective for treating diarrhea and possibly individuals with ulcerative colitis (UC). We will test the effects of 3 strains of probiotic bacteria on UC. In addition to standard medical care for UC, participants will consume a dietary supplement of 3 probiotic bacteria (Kyo-Dophilus; Lacobacillus acidophilus, Bifidobacterium bifidum, and Bifidobacterium longum) for 6 weeks. Changes in clinical symptoms and physiological markers of systemic and GI inflammation in subjects with UC will be assessed. Significant effects of the probiotics will be determined by comparing pre- and post-probiotic treatment measures for disease severity and level of inflammation and by comparing the probiotic treated group with the placebo treated control group. Any placebo effect on UC will also be assessed.
Forty subjects with ulcerative colitis will be recruited for the study and be provided a dietary supplement (5x109 bacteria/capsule, twice a day) for 6 weeks to 1/2 of the subjects and 1/2 of the UC subjects will be given a placebo control (potato starch). Standard medical care and therapies will be continued throughout the study. Initially, the physician will complete the Ulcerative Colitis Disease Activity Index (UCDAI) and the participants will complete the Shortened Inflammatory Bowel Disease Questionnaire (SIBDQ), and biopsies collected for histopathological assessment and analysis of inflammatory cytokine production (mRNA). Also, 30 ml of venous blood will be collected from each subject for analysis of serum/plasma levels of inflammatory cytokines and stress hormones. Subjects will be randomly assigned to the probiotic or placebo group (blinded to the physicians). After consuming the dietary supplement or placebo for 6 weeks, subjects will complete the SIBDQ questionnaire, the physician complete the UCDAI, be examined by sigmoidoscopy and tissue biopsies and blood samples collected. Also, during the 6 weeks of treatment, subjects will maintain a daily diary of their bowel habits. Data analysis will determine whether, relative to placebo controls, consumption of probiotics reduces the symptoms and levels of intestinal inflammation in patients with ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- Kyo-Dophilus, placebo
- Keywords
- ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kyo-DophilusDietary supplement
5x109 bacteria/capsule, twice a day, 1 in the morning, 1 in the evening
placeboDietary supplement
placebo capsules (potato starch
| Study group | Role | What they receive |
|---|---|---|
| Kyo-Dophilus | Active comparator | Kyo-Dophilus (5x109 bacteria/capsule, twice a day, 1 in the morning, 1 in the evening) Receives: Dietary Supplement: Kyo-Dophilus |
| Placebo | Placebo comparator | placebo capsules (potato starch) Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The UCDAI (Ulcerative Colitis Disease Activity Index) scores will be used to measure disease remission
Measured: 2 years
Results of patient questionnaires.
Measured: 2 years
Histopathological scoring of disease activity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: Non applicable clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Wakunaga Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Dwight M Nance, Ph.D, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578799
- Sponsor's protocol ID
- OCRT07053 [2007-6028]
- Status last verified
- Jan 2021
- First submitted
- 18 Dec 2007
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotics in Patients With Ulcerative Colitis.
- ClinicalTrials.gov ID
- NCT00578799
- Acronym / sponsor ID
- OCRT07053 [2007-6028]
- Conditions
- Ulcerative Colitis
- Keywords
- ulcerative colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Non applicable clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Wakunaga Pharmaceutical Co., Ltd.
- Study start
- Dec 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted in patients who have been diagnosed with ulcerative colitis (UC), a form of inflammatory bowel disease (IBD) - a disease of the intestine.
The purpose of this study is to test the therapeutic (medical treatment) effects of daily consumption of Kyo-Dophilus (a commercially available dietary supplement often used by individuals with inflammatory bowel disease) on their UC. Kyo-Dophilus consists of three probiotic bacteria (beneficial bacteria to help maintain the balance of good bacteria in the intestine) to help treat inflammatory bowel disease caused by bad bacteria. Patients will still be maintained on their clinical standard of care for their UC as part of their participation in this study.
Detailed description
Probiotics are defined as "live microorganisms, which, when administered in adequate amounts, confer a health benefit on the host." Most probiotics are lactic acid producing bacteria that are endogenous to the human GI (gastrointestinal) tract and are commonly utilized in the fermentation of food products, such as yogurt. Disturbances in the composition of the bacterial flora of the GI tract are associated with diarrhea and inflammatory bowel disease (IBD), and consumption of some strains of probiotic bacteria are very effective for treating diarrhea and possibly individuals with ulcerative colitis (UC). We will test the effects of 3 strains of probiotic bacteria on UC. In addition to standard medical care for UC, participants will consume a dietary supplement of 3 probiotic bacteria (Kyo-Dophilus; Lacobacillus acidophilus, Bifidobacterium bifidum, and Bifidobacterium longum) for 6 weeks. Changes in clinical symptoms and physiological markers of systemic and GI inflammation in subjects with UC will be assessed. Significant effects of the probiotics will be determined by comparing pre- and post-probiotic treatment measures for disease severity and level of inflammation and by comparing the probiotic treated group with the placebo treated control group. Any placebo effect on UC will also be assessed.
Forty subjects with ulcerative colitis will be recruited for the study and be provided a dietary supplement (5x109 bacteria/capsule, twice a day) for 6 weeks to 1/2 of the subjects and 1/2 of the UC subjects will be given a placebo control (potato starch). Standard medical care and therapies will be continued throughout the study. Initially, the physician will complete the Ulcerative Colitis Disease Activity Index (UCDAI) and the participants will complete the Shortened Inflammatory Bowel Disease Questionnaire (SIBDQ), and biopsies collected for histopathological assessment and analysis of inflammatory cytokine production (mRNA). Also, 30 ml of venous blood will be collected from each subject for analysis of serum/plasma levels of inflammatory cytokines and stress hormones. Subjects will be randomly assigned to the probiotic or placebo group (blinded to the physicians). After consuming the dietary supplement or placebo for 6 weeks, subjects will complete the SIBDQ questionnaire, the physician complete the UCDAI, be examined by sigmoidoscopy and tissue biopsies and blood samples collected. Also, during the 6 weeks of treatment, subjects will maintain a daily diary of their bowel habits. Data analysis will determine whether, relative to placebo controls, consumption of probiotics reduces the symptoms and levels of intestinal inflammation in patients with ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kyo-Dophilus | Active comparator | Dietary Supplement: Kyo-DophilusKyo-Dophilus (5x109 bacteria/capsule, twice a day, 1 in the morning, 1 in the evening) |
| Placebo | Placebo comparator | Dietary Supplement: placeboplacebo capsules (potato starch) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- We will be studying patients with mild to moderate active ulcerative colitis (UC).
- Patients are eligible to participate if:
- Subjects will not have consumed any fermented products, such as yogurt, for at least 6 weeks prior to being entered into the trial.
Key exclusion criteria (7 listed)
- Subjects will be excluded if they have the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kyo-Dophilus5x109 bacteria/capsule, twice a day, 1 in the morning, 1 in the evening | Dietary supplement | Kyo-Dophilus |
| placeboplacebo capsules (potato starch | Dietary supplement | Placebo |
Primary outcome
The UCDAI (Ulcerative Colitis Disease Activity Index) scores will be used to measure disease remission
Time frame: 2 years
Results of patient questionnaires.
Time frame: 2 years
Histopathological scoring of disease activity
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dwight M Nance, Ph.D principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Kyo-Dophilus in people with Ulcerative Colitis, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The UCDAI (Ulcerative Colitis Disease Activity Index) scores will be used to measure disease remission (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.