Irritable Bowel SyndromeMPH_IBSNCT03801057
Marine Protein Hydrolysate as Dietary Supplement in Irritable Bowel Syndrome
A study testing MPH_active in people with Irritable Bowel Syndrome, run by Helse Møre og Romsdal HF at 2 sites in Norway.
Trial summary
The use of natural bioactive products for prevention and treatment of a wide spectrum of conditions, including gastrointestinal disorders and conditions is well known. Based on current evidences, the scientific validity of such products is limited. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- MPH_active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesNorway
- Study dates
- 14 Jan 2019to 21 Apr 2019
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Body mass index (BMI) 18-30 kg/m2
- Irritable Bowel Syndrome (IBS) diagnosis according to Rome IV criteria
Who cannot join
- Suspected allergies against fish or shellfish
- Low or unstable blood pressure
- Diabetes mellitus pharmacologically treated
- Chronic diseases or therapies that are likely to interfere with the evaluation of study results such as known inflammation
- Acute infections (may be reconsidered for inclusion at a later time)
- Substance misuse
Show all 11Show fewer
- Inability or unwillingness to comply with the requirements of study procedures
- Individuals in the middle of testing different dietary strategies for the treatment of IBS (such as the low-FODMAP diet) and/or not willing to/able to maintain a stable diet throughout the study period
- Use of pro- or prebiotic supplements
- Use of antibiotic treatment for the last 4 weeks
- Immunocompromised patient defined as taking immuno-suppressive medications
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Ålesund Hospital, Helse Møre og Romsdal HF
Ålesund
Haukeland University Hospital
Bergen
About this study
Official title: The Effect of a Marine Protein Hydrolysate Supplement on Inflammatory Markers, Microbiota Composition and Symptoms in Patients With Irritable Bowel Syndrome
The use of natural bioactive products for prevention and treatment of a wide spectrum of conditions, including gastrointestinal disorders and conditions is well known. Based on current evidences, the scientific validity of such products is limited. However, there is sufficient preliminary data to indicate that bioactive compounds may be novel for potentially clinical use, thus further clinical trials investigating effect are needed. This trial is meant to evaluate the effect of an marine protein hydrolysate (MPH) supplement on composition of microbiota, inflammatory markers and symptom severity in people diagnosed with irritable bowel syndrome.
Read the detailed description
Previous studies performed in rodents have found that hydrolyzed proteins from fish alters the lipid and cholesterol metabolism, reduce plasma cholesterol and triglyceride levels and alters the fatty acid composition in liver and adipose tissue. Previous studies in humans have found marine peptides to have both antihypertensive and antioxidant effects. It is also suggested that fish protein hydrolysates may have an immunomodulating effect with beneficial properties in the intestine, and may prevent NSAID-induced injuries, change permeability in the gut and possibly prevent injurious conditions in the gut.
The evidence and knowledge are limited on the interaction between diet, gut microbiota and the influence of specific nutrients, as well as the impact of different sources of proteins on inflammation markers, gut microbiota and symptom severity in patients with irritable bowel syndrome (IBS). Different dietary sources of protein affect the diversity and composition of the human gut microbiota in different degree, demonstrated by a distinct gut bacteria profile observed between omnivores and vegetarians.The specific effect of marine peptides on human gut microbiota composition is as far as the investigators know, previously not investigated. Interestingly, novel results indicate that the presence of fish proteins in the diet have impact on both composition and activity of the gut microbiome, influencing the human microbiota composition.
The many benefits of expanding the utilization of marine products, the previous assumed beneficial intestinal effect and the increased interest in gut health and microbiota, as well as a great need for novel dietary treatment strategies for patients with irritable bowel syndrome (IBS) make this study warrant.
Aim with this trial is to evaluate the effect of an marine protein hydrolysate (MPH) supplement on composition of microbiota, inflammatory markers and symptom severity in human subjects diagnosed with IBS.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- MPH_active, MPH_placebo
- Keywords
- Dietary Supplements, Fish Proteins, Protein Hydrolysates
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPH_activeDietary supplement
One daily intake at breakfast of supplementary marine protein hydrolysate (MPH), a dosage of 2400 mg, duration 6 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water. Random sequence of arms.
MPH_placeboDietary supplement
One daily intake at breakfast of supplementary placebo, a dosage of 2400 mg, duration 6 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water.
| Study group | Role | What they receive |
|---|---|---|
| MPH_active | Active comparator | Daily intake at breakfast of supplementary marine protein hydrolysate (MPH). Random sequence of arms. Receives: Dietary Supplement: MPH_active |
| MPH_placebo | Placebo comparator | Daily intake at breakfast of supplementary placebo. Random sequence of arms. Receives: Dietary Supplement: MPH_placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS-SSS
A decrease of 50 points or more in IBS-SSS, which is a clinically meaningful improvement.The IBS-SSS is a 5-question survey that asks the severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life over the past 10 days. Subjects respond to each question on a 100-point visual analogue scale. Scores on the IBS-SSS can range from 0 to 500 with higher scores indicating more severe symptoms. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (>300) IBS.
Measured: Before (baseline) and after intervention (6 weeks later).
Secondary outcomes (2)
SF-NDI_HRQOL
The Short Form (SF) Nepean Dyspepsia Index is a 10-item questionnaire with 5 sub-scales each examining the influence of dyspepsia on domains of health in patients, namely tension/anxiety, interference with daily activities, disruption to regular eating/drinking, knowledge towards/control over disease symptoms and interference with work/study, with each sub-scale containing two items . Each item is measured by a 5-point Likert scale ranging from 0 (not at all or not applicable), 1 (a little), 2 (moderately), 3 (quite a lot) to 4 (extremely). Individual items in each sub-scale are aggregated to obtain a score range from 0 (lowest HRQoL score) to 100 (highest HRQoL score) as per the developers' original calculation formula. A total, overall SF-NDI total score is obtained using the mean of 5 subscale scores.
Measured: Before (baseline) and after intervention (6 weeks later).
Fecal Calprotectin
Calprotectin is a protein found in several human fluids. When detected in the stool, calprotectin has a direct relationship (consequence of neutrophil degranulation) to inflammation in the bowel.
Measured: Before (baseline) and after intervention (6 weeks later).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start14 Jan 2019
- Primary completion21 Mar 2019
- Study completion21 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel group randomized, controlled clinical trial for six weeks
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Møre og Romsdal HF
- Sponsor type
- Other government
- Collaborators
- Haukeland University Hospital, University of Bergen
- Responsible party
- Sponsor
- Investigators
- Dag Arne Lihaug Hoff, MD, PhD, Study director, Helse Møre og Romsdal Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801057
- Sponsor's protocol ID
- 2018/1825
- Acronym
- MPH_IBS
- Status last verified
- Aug 2019
- First submitted
- 9 Jan 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dale HF, Jensen C, Hausken T, Valeur J, Hoff DAL, Lied GA. Effects of a Cod Protein Hydrolysate Supplement on Symptoms, Gut Integrity Markers and Fecal Fermentation in Patients with Irritable Bowel Syndrome. Nutrients. 2019 Jul 17;11(7):1635. doi: 10.3390/nu11071635.
PubMed 31319590
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Marine Protein Hydrolysate Supplement on Inflammatory Markers, Microbiota Composition and Symptoms in Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT03801057
- Acronym / sponsor ID
- MPH_IBS / 2018/1825
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Dietary Supplements, Fish Proteins, Protein Hydrolysates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Helse Møre og Romsdal HFOther government
- Collaborators
- Haukeland University Hospital, University of Bergen
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 21 Mar 2019 (actual)
- Study completion
- 21 Apr 2019 (actual)
- First posted
- 11 Jan 2019 (actual)
- 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.
The use of natural bioactive products for prevention and treatment of a wide spectrum of conditions, including gastrointestinal disorders and conditions is well known. Based on current evidences, the scientific validity of such products is limited. However, there is sufficient preliminary data to indicate that bioactive compounds may be novel for potentially clinical use, thus further clinical trials investigating effect are needed. This trial is meant to evaluate the effect of an marine protein hydrolysate (MPH) supplement on composition of microbiota, inflammatory markers and symptom severity in people diagnosed with irritable bowel syndrome.
Detailed description
Previous studies performed in rodents have found that hydrolyzed proteins from fish alters the lipid and cholesterol metabolism, reduce plasma cholesterol and triglyceride levels and alters the fatty acid composition in liver and adipose tissue. Previous studies in humans have found marine peptides to have both antihypertensive and antioxidant effects. It is also suggested that fish protein hydrolysates may have an immunomodulating effect with beneficial properties in the intestine, and may prevent NSAID-induced injuries, change permeability in the gut and possibly prevent injurious conditions in the gut.
The evidence and knowledge are limited on the interaction between diet, gut microbiota and the influence of specific nutrients, as well as the impact of different sources of proteins on inflammation markers, gut microbiota and symptom severity in patients with irritable bowel syndrome (IBS). Different dietary sources of protein affect the diversity and composition of the human gut microbiota in different degree, demonstrated by a distinct gut bacteria profile observed between omnivores and vegetarians.The specific effect of marine peptides on human gut microbiota composition is as far as the investigators know, previously not investigated. Interestingly, novel results indicate that the presence of fish proteins in the diet have impact on both composition and activity of the gut microbiome, influencing the human microbiota composition.
The many benefits of expanding the utilization of marine products, the previous assumed beneficial intestinal effect and the increased interest in gut health and microbiota, as well as a great need for novel dietary treatment strategies for patients with irritable bowel syndrome (IBS) make this study warrant.
Aim with this trial is to evaluate the effect of an marine protein hydrolysate (MPH) supplement on composition of microbiota, inflammatory markers and symptom severity in human subjects diagnosed with IBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A parallel group randomized, controlled clinical trial for six weeks
| Arm | Type | Receives |
|---|---|---|
| MPH_active | Active comparator | Dietary Supplement: MPH_activeDaily intake at breakfast of supplementary marine protein hydrolysate (MPH). Random sequence of arms. |
| MPH_placebo | Placebo comparator | Dietary Supplement: MPH_placeboDaily intake at breakfast of supplementary placebo. Random sequence of arms. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent
- Body mass index (BMI) 18-30 kg/m2
- Irritable Bowel Syndrome (IBS) diagnosis according to Rome IV criteria
Key exclusion criteria (11 listed)
- Suspected allergies against fish or shellfish
- Low or unstable blood pressure
- Diabetes mellitus pharmacologically treated
- Chronic diseases or therapies that are likely to interfere with the evaluation of study results such as known inflammation
- Acute infections (may be reconsidered for inclusion at a later time)
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 |
|---|---|---|
| MPH_activeOne daily intake at breakfast of supplementary marine protein hydrolysate (MPH), a dosage of 2400 mg, duration 6 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water. Random sequence of arms. | Dietary supplement | MPH_active |
| MPH_placeboOne daily intake at breakfast of supplementary placebo, a dosage of 2400 mg, duration 6 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water. | Dietary supplement | MPH_placebo |
Primary outcome
IBS-SSS
Time frame: Before (baseline) and after intervention (6 weeks later).
A decrease of 50 points or more in IBS-SSS, which is a clinically meaningful improvement.The IBS-SSS is a 5-question survey that asks the severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life over the past 10 days. Subjects respond to each question on a 100-point visual analogue scale. Scores on the IBS-SSS can range from 0 to 500 with higher scores indicating more severe symptoms. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (>300) IBS.
2 secondary outcomes
SF-NDI_HRQOL
Time frame: Before (baseline) and after intervention (6 weeks later).
Fecal Calprotectin
Time frame: Before (baseline) and after intervention (6 weeks later).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Results publication: PubMed 31319590Dale HF, Jensen C, Hausken T, Valeur J, Hoff DAL, Lied GA. Effects of a Cod Protein Hydrolysate Supplement on Symptoms, Gut Integrity Markers and Fecal Fermentation in Patients with Irritable Bowel Syndrome. Nutrients. 2019 Jul 17;11(7):1635. doi: 10.3390/nu11071635.
- Individual participant dataSharing planned: Undecided
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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.
Dag Arne Lihaug Hoff, MD, PhD study director
Helse Møre og Romsdal Hospital Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPH_active in people with Irritable Bowel Syndrome, run by Helse Møre og Romsdal HF at 2 sites in Norway.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IBS-SSS (time frame: Before (baseline) and after intervention (6 weeks later).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03801057, which also lists 1 linked publication.
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 14 Aug 2019.