Functional Bowel DisorderNCT06338189
The 5Ad Diet for Functional Bowel Disorders
A study testing The 5Ad Diet and The Low FODMAP Diet in people with Functional Bowel Disorder and Irritable Bowel Syndrome, run by University of Suffolk at 1 site in United Kingdom.
Trial summary
The goal of this randomised controlled trial (RCT) is to compare the efficacy of the newly developed 5Ad diet against the widely researched low fermentable oligo-, di-, monosaccharide and polyols (FODMAP) diet in reducing gastrointestinal symptoms associated with functional bowel disorders/food intolerances. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functional Bowel Disorder, Irritable Bowel Syndrome, Food Intolerance
- What is being tested?
- The 5Ad Diet and The Low FODMAP Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 May 2022to 1 Apr 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals are eligible for the study if all of the following criteria are met:
- Suffers chronically from either constipation, diarrhoea, or an alternation of both, bloating, flatulence or abdominal pain, incomplete defecation, straining and bowel urgency.
- Symptoms must be present for ≥ 2 times per week, with symptom onset occurring at least 3 months prior to participation.
- Participants taking prescribed medications which may affect bowel function are included only if the intake is maintained throughout the entire intervention period.
Who cannot join
- Individuals are excluded from the study if any of the following criteria are met:
- Pregnant.
- Known underlying pathology (e.g., Crohn's disease, ulcerative colitis, celiac disease).
- History of abdominal/gastrointestinal surgery within 1 year prior to participation.
- History of antibiotic use in the last 6 weeks prior to participation.
- Allergic to the foods specified in both the 5Ad diet and the low FODMAP diet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The 5Ad Diet for Functional Bowel Disorders: A Randomised Controlled Trial Against the Low FODMAP Diet
The goal of this randomised controlled trial (RCT) is to compare the efficacy of the newly developed 5Ad diet against the widely researched low fermentable oligo-, di-, monosaccharide and polyols (FODMAP) diet in reducing gastrointestinal symptoms associated with functional bowel disorders/food intolerances.
The primary aims of this RCT are to determine:
Read more
- Whether the 5Ad diet is at least as effective as the low FODMAP diet in reducing gastrointestinal symptoms associated with FBDs/food intolerances.
- Whether either the 5Ad diet or the low FODMAP diet are effective in reducing mental and physical fatigue.
To achieve the above aims, an RCT will be conducted with the 5Ad diet in one arm vs the active phase of the low FODMAP diet in the other arm, in a cross-over design with a 7 days washout phase in between. Both dietary protocols will be followed by each participant for 7 days.
Researchers will compare the results from the 2 dietary protocols in order to ascertain the superiority of one over the other in regards to 6 gastrointestinal symptoms (abdominal pain, bloating, flatulence, bowel urgency, straining and incomplete defecation), stool form and frequency of defecation.
Read the detailed description
Functional Bowel Disorders (FBDs) are characterised by chronic gastrointestinal symptoms including abdominal pain, constipation, bloating, diarrhoea, alternating abdominal symptoms, and irregular frequency of bowel movements among others in the absence of any intestinal abnormality. The prevalence of FBDs ranges from 15 - 20% worldwide, with remarkable economic burden on health systems and significant impact on the quality of life of sufferers. It is estimated that between 60% - 89% of individuals that suffer from FBDs find that foods exacerbate their symptoms. Therefore, dietary therapies are frequently implemented to assist with symptom relief in these individuals.
Although the low FODMAP diet is the most commonly followed diet for the treatment of FBDs, there are concerns regarding it's complexity, restrictiveness, nutritional adequacy, and effectiveness. Therefore, the 5Ad diet was designed to fill a gap in the existing research and to overcome the limitations associated with existing dietary approaches.
Preliminary findings from the first study in 2019 suggested that the 5Ad diet might be a promising universal approach for varying forms and severities of FBDs. Therefore, an RCT is needed to substantiate these previous results. Thus, this RCT aims to determine whether the 5Ad diet is at least as effective as the low FODMAP diet in reducing gastrointestinal symptoms associated with FBDs/food intolerances.
- Conditions
- Functional Bowel Disorder, Irritable Bowel Syndrome, Food Intolerance, Food Intolerance Syndromes
- Being tested
- The 5Ad Diet, The Low FODMAP Diet
- Keywords
- The 5Ad Diet, The Low FODMAP Diet, Irritable Bowel Syndrome, Functional Constipation, Functional Diarrhoea, Functional Bloating
- Medical subject headings
- Irritable Bowel Syndrome, Food Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The 5Ad DietOther
Participants are to follow the 5Ad diet.
The Low FODMAP DietOther
Participants are to follow the active phase of the Low FODMAP diet.
| Study group | Role | What they receive |
|---|---|---|
| The 5Ad Diet | Active comparator | Participants are required to follow the 5Ad diet for 7 days, followed by a washout phase for 7 days, before crossing over to the active phase of the low FODMAP diet for 7 days. Receives: Other: The 5Ad Diet; Other: The Low FODMAP Diet |
| The Low FODMAP Diet | Active comparator | Participants are required to follow the active phase of the low FODMAP diet for 7 days, followed by a washout phase for 7 days, before crossing over to the 5Ad diet for 7 days. Receives: Other: The 5Ad Diet; Other: The Low FODMAP Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Pain
Abdominal pain will be recorded daily in a symptom diary and measured using a 4 point Likert-type scale, coded from 0 - 10 for conversion into continuous variables (None = 0; Mild = 1 - 3; Moderate = 4 - 6 ; Severe = 7 - 10).
Measured: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
Abdominal Bloating
Abdominal bloating will be recorded daily in a symptom diary and measured using a 4 point Likert-type scale, coded from 0 - 10 for conversion into continuous variables (None = 0; Mild = 1 - 3; Moderate = 4 - 6 ; Severe = 7 - 10).
Measured: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
Flatulence
Flatulence will be recorded daily in a symptom diary and measured using a 4 point Likert-type scale, coded from 0 - 10 for conversion into continuous variables (None = 0; Mild = 1 - 3; Moderate = 4 - 6 ; Severe = 7 - 10).
Measured: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
Bowel Urgency
Bowel urgency will be recorded daily in a symptom diary and measured using a 4 point Likert-type scale, coded from 0 - 10 for conversion into continuous variables (None = 0; Mild = 1 - 3; Moderate = 4 - 6 ; Severe = 7 - 10).
Measured: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
Straining
Straining will be recorded daily in a symptom diary and measured using a 4 point Likert-type scale, coded from 0 - 10 for conversion into continuous variables (None = 0; Mild = 1 - 3; Moderate = 4 - 6 ; Severe = 7 - 10).
Measured: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
Incomplete Defecation
Incomplete defection will be recorded daily in a symptom diary and measured using a 4 point Likert-type scale, coded from 0 - 10 for conversion into continuous variables (None = 0; Mild = 1 - 3; Moderate = 4 - 6 ; Severe = 7 - 10).
Measured: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
Stool Form
Stool form will be measured using the Bristol Stool Form Scale. Type 1 - Separate hard lumps, like nuts (hard to pass), Type 2 - Sausage shaped, but lumpy, Type 3 - Like a sausage but with cracks on its surface, Type 4 - Like a sausage or snake, smooth and soft, Type 5 - Soft blobs with clear cut edges (passed easily), Type 6 - Fluffy pieces with ragged edges, a mushy stool, and Type 7 - Watery, no solid pieces, entirely liquid. Stool Types 1 and 2 are associated with constipation, while stool Types 5 - 7 are associated with diarrhoea. Stool Types 3 and 4 are considered normal stools.
Measured: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
Frequency of defecation
Frequency of defecation will be recorded daily in a symptom diary.
Measured: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
Secondary outcomes (3)
Fatigue
Fatigue will be recorded and measured using the Fatigue Assessment Scale (FAS) (Michielsen et al., 2003), using a 5 point Likert-type scale, coded from 1 - 5 for conversion into continuous variables (None = 1; Sometimes = 2; Regularly = 3; Often = 4; Always = 5). Question 1 - I am bothered by fatigue; Question 2 - I get tired very quickly; Question 3 - I don't do much during the day; Question 4 - I have enough energy for everyday life; Question 5 - Physically, I feel exhausted; Question 6 - I have problems starting things; Question 7 - I have problems thinking clearly; Question 8 - I feel no desire to do anything; Question 9 - Mentally, I feel exhausted and Question 10 - When I am doing something, I can concentrate quite well. Question 4 and 10 are to be reverse scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.
Measured: Assessed on the last day of both dietary protocols (Day 7 of each dietary protocol)
Mental Fatigue
Mental fatigue will be measured using the Fatigue Assessment Scale (FAS), using a 5 point Likert-type scale, coded from 1 - 5 for conversion into continuous variables (None = 1; Sometimes = 2; Regularly = 3; Often = 4; Always = 5). Only questions 6 - 10 will be used to calculate the mental fatigue score. Question 6 - I have problems starting things; Question 7 - I have problems thinking clearly; Question 8 - I feel no desire to do anything; Question 9 - Mentally, I feel exhausted and Question 10 - When I am doing something, I can concentrate quite well. Question 10 is to be reverse scored. Total scores can range from 5, indicating the lowest level of fatigue, to 25, denoting the highest.
Measured: Assessed on the last day of both dietary protocols (Day 7 of each dietary protocol)
Physical Fatigue
Physical fatigue will be measured using the Fatigue Assessment Scale (FAS), using a 5 point Likert-type scale, coded from 1 - 5 for conversion into continuous variables (None = 1; Sometimes = 2; Regularly = 3; Often = 4; Always = 5). Only questions 1 - 5 will be used to calculate the mental fatigue score. Question 1 - I am bothered by fatigue; Question 2 - I get tired very quickly; Question 3 - I don't do much during the day; Question 4 - I have enough energy for everyday life; Question 5 - Physically, I feel exhausted. Question 4 is to be reverse scored. Total scores can range from 5, indicating the lowest level of fatigue, to 25, denoting the highest.
Measured: Assessed on the last day of both dietary protocols (Day 7 of each dietary protocol)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start8 May 2022
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Functional Bowel DisorderStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Suffolk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilla Bunn, University of Suffolk
- Investigators
- Camilla Bunn, Principal investigator, University of Suffolk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338189
- Sponsor's protocol ID
- USuffolk
- Status last verified
- Nov 2025
- First submitted
- 15 Mar 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ibrahim F, Stribling P. A 5Ad Dietary Protocol for Functional Bowel Disorders. Nutrients. 2019 Aug 17;11(8):1938. doi: 10.3390/nu11081938.
PubMed 31426496Ibrahim F, Stribling P. Reply to "A Gluten Reduction Is the Patients' Choice for a Dietary 'Bottom Up' Approach in IBS-A Comment on "A 5Ad Dietary Protocol for Functional Bowel Disorders" Nutrients 2019, 11, 1938". Nutrients. 2020 Jan 3;12(1):140. doi: 10.3390/nu12010140.
PubMed 31947828Gibson PR, Shepherd SJ. Personal view: food for thought--western lifestyle and susceptibility to Crohn's disease. The FODMAP hypothesis. Aliment Pharmacol Ther. 2005 Jun 15;21(12):1399-409. doi: 10.1111/j.1365-2036.2005.02506.x.
PubMed 15948806Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.
PubMed 9299672Michielsen HJ, De Vries J, Van Heck GL. Psychometric qualities of a brief self-rated fatigue measure: The Fatigue Assessment Scale. J Psychosom Res. 2003 Apr;54(4):345-52. doi: 10.1016/s0022-3999(02)00392-6.
PubMed 12670612
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 5Ad Diet for Functional Bowel Disorders: A Randomised Controlled Trial Against the Low FODMAP Diet
- ClinicalTrials.gov ID
- NCT06338189
- Acronym / sponsor ID
- USuffolk
- Conditions
- Functional Bowel Disorder, Irritable Bowel Syndrome, Food Intolerance, Food Intolerance Syndromes
- Keywords
- The 5Ad Diet, The Low FODMAP Diet, Irritable Bowel Syndrome, Functional Constipation, Functional Diarrhoea, Functional Bloating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of SuffolkUniversity, hospital or other
- Study start
- 8 May 2022 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 29 Mar 2024 (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 goal of this randomised controlled trial (RCT) is to compare the efficacy of the newly developed 5Ad diet against the widely researched low fermentable oligo-, di-, monosaccharide and polyols (FODMAP) diet in reducing gastrointestinal symptoms associated with functional bowel disorders/food intolerances.
The primary aims of this RCT are to determine:
- Whether the 5Ad diet is at least as effective as the low FODMAP diet in reducing gastrointestinal symptoms associated with FBDs/food intolerances.
- Whether either the 5Ad diet or the low FODMAP diet are effective in reducing mental and physical fatigue.
To achieve the above aims, an RCT will be conducted with the 5Ad diet in one arm vs the active phase of the low FODMAP diet in the other arm, in a cross-over design with a 7 days washout phase in between. Both dietary protocols will be followed by each participant for 7 days.
Researchers will compare the results from the 2 dietary protocols in order to ascertain the superiority of one over the other in regards to 6 gastrointestinal symptoms (abdominal pain, bloating, flatulence, bowel urgency, straining and incomplete defecation), stool form and frequency of defecation.
Detailed description
Functional Bowel Disorders (FBDs) are characterised by chronic gastrointestinal symptoms including abdominal pain, constipation, bloating, diarrhoea, alternating abdominal symptoms, and irregular frequency of bowel movements among others in the absence of any intestinal abnormality. The prevalence of FBDs ranges from 15 - 20% worldwide, with remarkable economic burden on health systems and significant impact on the quality of life of sufferers. It is estimated that between 60% - 89% of individuals that suffer from FBDs find that foods exacerbate their symptoms. Therefore, dietary therapies are frequently implemented to assist with symptom relief in these individuals.
Although the low FODMAP diet is the most commonly followed diet for the treatment of FBDs, there are concerns regarding it's complexity, restrictiveness, nutritional adequacy, and effectiveness. Therefore, the 5Ad diet was designed to fill a gap in the existing research and to overcome the limitations associated with existing dietary approaches.
Preliminary findings from the first study in 2019 suggested that the 5Ad diet might be a promising universal approach for varying forms and severities of FBDs. Therefore, an RCT is needed to substantiate these previous results. Thus, this RCT aims to determine whether the 5Ad diet is at least as effective as the low FODMAP diet in reducing gastrointestinal symptoms associated with FBDs/food intolerances.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The 5Ad Diet | Active comparator | Other: The 5Ad Diet, Other: The Low FODMAP DietParticipants are required to follow the 5Ad diet for 7 days, followed by a washout phase for 7 days, before crossing over to the active phase of the low FODMAP diet for 7 days. |
| The Low FODMAP Diet | Active comparator | Other: The 5Ad Diet, Other: The Low FODMAP DietParticipants are required to follow the active phase of the low FODMAP diet for 7 days, followed by a washout phase for 7 days, before crossing over to the 5Ad diet for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Suffers chronically from either constipation, diarrhoea, or an alternation of both, bloating, flatulence or abdominal pain, incomplete defecation, straining and bowel urgency.
- Symptoms must be present for ≥ 2 times per week, with symptom onset occurring at least 3 months prior to participation.
- Participants taking prescribed medications which may affect bowel function are included only if the intake is maintained throughout the entire intervention period.
Key exclusion criteria (6 listed)
- Pregnant.
- Known underlying pathology (e.g., Crohn's disease, ulcerative colitis, celiac disease).
- History of abdominal/gastrointestinal surgery within 1 year prior to participation.
- History of antibiotic use in the last 6 weeks prior to participation.
- Allergic to the foods specified in both the 5Ad diet and the low FODMAP diet.
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 |
|---|---|---|
| The 5Ad DietParticipants are to follow the 5Ad diet. | Other | The 5Ad Diet, The Low FODMAP Diet |
| The Low FODMAP DietParticipants are to follow the active phase of the Low FODMAP diet. | Other | The 5Ad Diet, The Low FODMAP Diet |
Primary outcome
Abdominal Pain
Time frame: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
Abdominal pain will be recorded daily in a symptom diary and measured using a 4 point Likert-type scale, coded from 0 - 10 for conversion into continuous variables (None = 0; Mild = 1 - 3; Moderate = 4 - 6 ; Severe = 7 - 10).
Abdominal Bloating
Time frame: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
Abdominal bloating will be recorded daily in a symptom diary and measured using a 4 point Likert-type scale, coded from 0 - 10 for conversion into continuous variables (None = 0; Mild = 1 - 3; Moderate = 4 - 6 ; Severe = 7 - 10).
Flatulence
Time frame: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
Flatulence will be recorded daily in a symptom diary and measured using a 4 point Likert-type scale, coded from 0 - 10 for conversion into continuous variables (None = 0; Mild = 1 - 3; Moderate = 4 - 6 ; Severe = 7 - 10).
Bowel Urgency
Time frame: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
Bowel urgency will be recorded daily in a symptom diary and measured using a 4 point Likert-type scale, coded from 0 - 10 for conversion into continuous variables (None = 0; Mild = 1 - 3; Moderate = 4 - 6 ; Severe = 7 - 10).
Straining
Time frame: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
Straining will be recorded daily in a symptom diary and measured using a 4 point Likert-type scale, coded from 0 - 10 for conversion into continuous variables (None = 0; Mild = 1 - 3; Moderate = 4 - 6 ; Severe = 7 - 10).
Incomplete Defecation
Time frame: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
Incomplete defection will be recorded daily in a symptom diary and measured using a 4 point Likert-type scale, coded from 0 - 10 for conversion into continuous variables (None = 0; Mild = 1 - 3; Moderate = 4 - 6 ; Severe = 7 - 10).
Stool Form
Time frame: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
Stool form will be measured using the Bristol Stool Form Scale. Type 1 - Separate hard lumps, like nuts (hard to pass), Type 2 - Sausage shaped, but lumpy, Type 3 - Like a sausage but with cracks on its surface, Type 4 - Like a sausage or snake, smooth and soft, Type 5 - Soft blobs with clear cut edges (passed easily), Type 6 - Fluffy pieces with ragged edges, a mushy stool, and Type 7 - Watery, no solid pieces, entirely liquid. Stool Types 1 and 2 are associated with constipation, while stool Types 5 - 7 are associated with diarrhoea. Stool Types 3 and 4 are considered normal stools.
Frequency of defecation
Time frame: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)
Frequency of defecation will be recorded daily in a symptom diary.
3 secondary outcomes
Fatigue
Time frame: Assessed on the last day of both dietary protocols (Day 7 of each dietary protocol)
Mental Fatigue
Time frame: Assessed on the last day of both dietary protocols (Day 7 of each dietary protocol)
Physical Fatigue
Time frame: Assessed on the last day of both dietary protocols (Day 7 of each dietary protocol)
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 24 Nov 2025.
- Background: PubMed 31426496Ibrahim F, Stribling P. A 5Ad Dietary Protocol for Functional Bowel Disorders. Nutrients. 2019 Aug 17;11(8):1938. doi: 10.3390/nu11081938.
- Background: PubMed 31947828Ibrahim F, Stribling P. Reply to "A Gluten Reduction Is the Patients' Choice for a Dietary 'Bottom Up' Approach in IBS-A Comment on "A 5Ad Dietary Protocol for Functional Bowel Disorders" Nutrients 2019, 11, 1938". Nutrients. 2020 Jan 3;12(1):140. doi: 10.3390/nu12010140.
- Background: PubMed 15948806Gibson PR, Shepherd SJ. Personal view: food for thought--western lifestyle and susceptibility to Crohn's disease. The FODMAP hypothesis. Aliment Pharmacol Ther. 2005 Jun 15;21(12):1399-409. doi: 10.1111/j.1365-2036.2005.02506.x.
- Background: PubMed 9299672Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.
- Background: PubMed 12670612Michielsen HJ, De Vries J, Van Heck GL. Psychometric qualities of a brief self-rated fatigue measure: The Fatigue Assessment Scale. J Psychosom Res. 2003 Apr;54(4):345-52. doi: 10.1016/s0022-3999(02)00392-6.
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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.
Camilla Bunn principal investigator
University of Suffolk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The 5Ad Diet and The Low FODMAP Diet in people with Functional Bowel Disorder and Irritable Bowel Syndrome, run by University of Suffolk at 1 site in United Kingdom.
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 4 inclusion and 6 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 24 Nov 2025. 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 Kingdom. 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. 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?
Abdominal Pain (time frame: Assessed daily throughout both dietary protocols (7 days for each dietary protocol)). The study lists 8 primary outcomes in all. 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 NCT06338189, which also lists 5 linked publications.
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 24 Nov 2025.