Adults 18 to 70, any sex, with Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Overall ResponsePrimary· Baseline up to Week 8
Overall responder was a participant who has at least 7 evaluable weeks of data and has reported an improvement in their weekly symptoms (abdominal pain intensity \[API\] and stool frequency \[SF\] or consistency \[SC\]) for greater than or equal to (\>=) 50 percent (%) of the treatment period. Improvement for abdominal pain intensity was defined as decrease in weekly average of worst abdominal pain in the past 24 hours score of at least 30% compared with baseline for Cohort C and Cohort D, for stool frequency was defined as increase of 1 or more complete spontaneous bowel movements (CSBM) per
Group
Value
95% CI
Cohort C: Blautix
25.0
Cohort C: Placebo
17.1
Cohort D: Blautix
23.4
Cohort D: Placebo
17.8
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs)Secondary· Baseline up to follow-up visit (up to Week 14)
An adverse event (AE) was any untoward medical occurrence in a participant administered study medication and which does not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE that started or worsened in severity on or after the start date of the study treatment and includes all AEs recorded through the follow-up visit. A treatment-related TEAE was a TEAE possibly related to the study treatment.
Group
Value
95% CI
Cohort C: Blautix
5
Cohort C: Placebo
4
Cohort D: Blautix
16
Cohort D: Placebo
14
Number of Participants With Response to Subject Global Assessment of ReliefSecondary· Week 1, 4, 8, follow-up visit (Week 12, 13 and 14)
The subject global assessment of relief was collected weekly through the electronic clinical outcome assessment (eCOA) system. It was a comparison of how the participant has felt over the past week with regards to their IBS to the way they felt before entering the study. It was measured on a 5-point Likert scale with the following responses: Completely relieved; considerably relieved; somewhat relieved; unchanged; worse. The total score ranged from 0-20, where higher scores indicated worsening of condition.
Week 1: Completely Relieved
Group
Value
95% CI
Cohort C: Blautix
0
Cohort C: Placebo
2
Cohort D: Blautix
2
Cohort D: Placebo
0
Week 1: Considerably Relieved
Group
Value
95% CI
Cohort C: Blautix
1
Cohort C: Placebo
3
Cohort D: Blautix
1
Cohort D: Placebo
0
Week 1: Somewhat Relieved
Group
Value
95% CI
Cohort C: Blautix
6
Cohort C: Placebo
6
Cohort D: Blautix
3
Cohort D: Placebo
8
Week 1: Unchanged
Group
Value
95% CI
Cohort C: Blautix
58
Cohort C: Placebo
56
Cohort D: Blautix
72
Cohort D: Placebo
76
Week 1: Worse
Group
Value
95% CI
Cohort C: Blautix
1
Cohort C: Placebo
3
Cohort D: Blautix
6
Cohort D: Placebo
2
Week 4: Completely Relieved
Group
Value
95% CI
Cohort C: Blautix
1
Cohort C: Placebo
1
Cohort D: Blautix
2
Cohort D: Placebo
1
Week 4: Considerably Relieved
Group
Value
95% CI
Cohort C: Blautix
13
Cohort C: Placebo
7
Cohort D: Blautix
13
Cohort D: Placebo
14
Week 4: Somewhat Relieved
Group
Value
95% CI
Cohort C: Blautix
31
Cohort C: Placebo
31
Cohort D: Blautix
26
Cohort D: Placebo
24
Change in Percentage of Days Per Week With Undesired Stool Consistency From Baseline at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14)Secondary· Baseline, Week 1, 4, 8, follow-up visit (Week 12, 13 and 14)
Stool consistency of each bowel movement was rated on 7-level Bristol Stool Chart where 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 the 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, Type 7 = watery, no solid pieces; entirely liquid. A score range of 1 to 7 where, 1 or 2 indicates constipation and a score of 6 or 7 indicates diarrhea. Change in percentage of days per week with at
Change at Week 1
Group
Value
95% CI
Cohort C: Blautix
0.13
± 22.859
Cohort C: Placebo
3.38
± 24.412
Cohort D: Blautix
-25.67
± 28.078
Cohort D: Placebo
-23.70
± 30.730
Change at Week 4
Group
Value
95% CI
Cohort C: Blautix
-4.23
± 24.470
Cohort C: Placebo
-1.99
± 24.077
Cohort D: Blautix
-32.43
± 33.627
Cohort D: Placebo
-33.73
± 33.615
Change at Week 8
Group
Value
95% CI
Cohort C: Blautix
-5.93
± 26.705
Cohort C: Placebo
-0.10
± 22.852
Cohort D: Blautix
-40.36
± 37.595
Cohort D: Placebo
-36.91
± 35.753
Change at Week 12
Group
Value
95% CI
Cohort C: Blautix
-5.66
± 23.063
Cohort C: Placebo
1.06
± 27.027
Cohort D: Blautix
-34.09
± 41.128
Cohort D: Placebo
-42.13
± 31.500
Change at Week 13
Group
Value
95% CI
Cohort C: Blautix
10.88
± 26.517
Cohort C: Placebo
-5.16
± 19.868
Cohort D: Blautix
-29.38
± 35.002
Cohort D: Placebo
-32.21
± 39.679
Change at Week 14
Group
Value
95% CI
Cohort C: Blautix
-15.48
± 1.684
Cohort C: Placebo
-2.98
± 15.994
Cohort D: Blautix
-40.00
± 36.216
Cohort D: Placebo
-38.10
± 36.608
Percent Change From Baseline in Stool Consistency Assessed by Bristol Stool Form Scale (BSFS) at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14)Secondary· Baseline, Week 1, 4, 8, follow-up visit (Week 12, 13 and 14)
Stool consistency of each bowel movement was assessed by participants using the 7-point BSFS from 1 to 7 where 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 the 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, Type 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation and a score of 6 or 7 indicates diarrhea. Lower numbers represented more formed stoo
Percent Change at Week 1
Group
Value
95% CI
Cohort C: Blautix
15.05
± 126.940
Cohort C: Placebo
27.65
± 129.217
Cohort D: Blautix
32.30
± 36.887
Cohort D: Placebo
-27.27
± 38.590
Percent Change at Week 4
Group
Value
95% CI
Cohort C: Blautix
-6.36
± 122.165
Cohort C: Placebo
-7.18
± 112.425
Cohort D: Blautix
-40.14
± 42.757
Cohort D: Placebo
-40.60
± 40.128
Percent Change at Week 8
Group
Value
95% CI
Cohort C: Blautix
-12.00
± 145.174
Cohort C: Placebo
-4.64
± 103.202
Cohort D: Blautix
-49.32
± 45.798
Cohort D: Placebo
-42.64
± 39.801
Percent Change at Week 12
Group
Value
95% CI
Cohort C: Blautix
-7.45
± 125.537
Cohort C: Placebo
14.75
± 144.064
Cohort D: Blautix
-36.96
± 50.023
Cohort D: Placebo
-49.94
± 34.638
Percent Change at Week 13
Group
Value
95% CI
Cohort C: Blautix
41.07
± 143.017
Cohort C: Placebo
-40.31
± 89.914
Cohort D: Blautix
-33.29
± 40.067
Cohort D: Placebo
-35.91
± 44.635
Percent Change at Week 14
Group
Value
95% CI
Cohort C: Blautix
-100.00
± 0.000
Cohort C: Placebo
-25.00
± 106.066
Cohort D: Blautix
-52.50
± 49.319
Cohort D: Placebo
-43.53
± 44.353
Change From Baseline in Weekly Average Stool Frequency Assessed by Bristol Stool Form Scale (BSFS) at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14)Secondary· Baseline, Week 1, 4, 8, follow-up visit (Week 12, 13 and 14)
Stool frequency was defined as a sum of weekly CSBMs. Participants were reminded to rate all their bowel movements in the Bristol Stool Chart (BSC) before answering the question. Stool types were assessed using the 7-point BSFS where 1 = separate hard lumps, like nuts (hard to pass), 2 = sausage-shaped but lumpy, 3 = like a sausage but with cracks on the surface, 4 = like a sausage or snake, smooth and soft, 5 = soft blobs with clear-cut edges (passed easily), 6 = fluffy pieces with ragged edges, a mushy stool, 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipat
Change at Week 1
Group
Value
95% CI
Cohort C: Blautix
1.33
± 2.202
Cohort C: Placebo
1.61
± 2.416
Cohort D: Blautix
-1.07
± 2.441
Cohort D: Placebo
-1.02
± 3.119
Change at Week 4
Group
Value
95% CI
Cohort C: Blautix
2.14
± 2.348
Cohort C: Placebo
1.87
± 2.809
Cohort D: Blautix
-1.60
± 2.543
Cohort D: Placebo
-1.83
± 3.389
Change at Week 8
Group
Value
95% CI
Cohort C: Blautix
2.00
± 2.289
Cohort C: Placebo
2.42
± 2.751
Cohort D: Blautix
-2.59
± 3.012
Cohort D: Placebo
-1.97
± 3.048
Change at Week 12
Group
Value
95% CI
Cohort C: Blautix
1.76
± 2.547
Cohort C: Placebo
2.18
± 2.762
Cohort D: Blautix
-2.29
± 2.599
Cohort D: Placebo
-2.43
± 3.299
Change at Week 13
Group
Value
95% CI
Cohort C: Blautix
2.09
± 2.489
Cohort C: Placebo
1.98
± 2.539
Cohort D: Blautix
-2.05
± 3.242
Cohort D: Placebo
-1.77
± 2.804
Change at Week 14
Group
Value
95% CI
Cohort C: Blautix
2.56
± 0.507
Cohort C: Placebo
1.19
± 0.860
Cohort D: Blautix
-4.71
± 2.626
Cohort D: Placebo
-3.54
± 4.063
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14)Secondary· Baseline, Week 4, 8, follow-up visit (Weeks 12-14)
Participants were asked to complete a QOL of 34 items which formed 8 scales: dysphoria (8 items), interference with activity (7 items), body image (4 items), health worry (3 items), food avoidance (3 items), social reaction (4 items), sexual (2 items), and relationships (3 items). All 8 scales were rated on a five-point response scale where, 1= not at all, 2= slightly, 3= moderately, 4= quite a bit, 5= extremely or a great deal. Scores for individual items were averaged to obtain a total score for each sub-scale of IBSQoL. Total and subscale scores were transformed to a 0 to 100 point scale (0
Change at Week 4: Total score
Group
Value
95% CI
Cohort C: Blautix
5.67
± 16.858
Cohort C: Placebo
5.79
± 21.908
Cohort D: Blautix
5.62
± 18.087
Cohort D: Placebo
5.93
± 13.113
Change at Week 4: Dysphoria score
Group
Value
95% CI
Cohort C: Blautix
5.95
± 20.561
Cohort C: Placebo
5.34
± 22.881
Cohort D: Blautix
9.17
± 22.627
Cohort D: Placebo
5.81
± 17.429
Change at Week 4: Interference with activity Score
Group
Value
95% CI
Cohort C: Blautix
4.79
± 16.952
Cohort C: Placebo
6.71
± 22.633
Cohort D: Blautix
7.54
± 18.230
Cohort D: Placebo
8.26
± 16.008
Change at Week 4: Body Image Score
Group
Value
95% CI
Cohort C: Blautix
4.88
± 23.779
Cohort C: Placebo
7.62
± 23.239
Cohort D: Blautix
5.83
± 20.703
Cohort D: Placebo
4.10
± 17.860
Change at Week 4: Health Worry Score
Group
Value
95% CI
Cohort C: Blautix
10.98
± 23.082
Cohort C: Placebo
10.57
± 26.940
Cohort D: Blautix
6.85
± 19.727
Cohort D: Placebo
7.55
± 19.056
Change at Week 4: Food Avoidance Score
Group
Value
95% CI
Cohort C: Blautix
6.50
± 20.625
Cohort C: Placebo
4.88
± 29.461
Cohort D: Blautix
5.56
± 19.624
Cohort D: Placebo
7.55
± 19.960
Change at Week 4: Social Reaction Score
Group
Value
95% CI
Cohort C: Blautix
4.12
± 16.922
Cohort C: Placebo
2.44
± 24.402
Cohort D: Blautix
0.42
± 23.963
Cohort D: Placebo
6.64
± 14.935
Change at Week 4: Sexual Score
Group
Value
95% CI
Cohort C: Blautix
7.32
± 29.445
Cohort C: Placebo
1.52
± 24.716
Cohort D: Blautix
-0.56
± 20.288
Cohort D: Placebo
0.39
± 19.284
Change From Baseline in IBS Symptom Severity Score (IBS-SSS) at Week 4, 8 and Follow-up Visit (Weeks 12-14)Secondary· Baseline, Week 4, 8, follow-up visit (Weeks 12-14)
Participants were asked to complete a questionnaire on the severity of abdominal distension and pain, frequency of abdominal pain, dissatisfaction with bowel habits, and interference of IBS symptoms with daily life. The IBS-SSS was measured on a Visual Analog Scale (VAS scale) in combination with reported numeric values which equated to an overall score. The scale range was from 0 (no symptoms) to 500 (maximum severity). Participants were categorized as having mild (74-174), moderate (175-299), or severe (\>300) IBS symptoms based on symptomology. Higher scores were indicative of greater disea
Change at Week 4
Group
Value
95% CI
Cohort C: Blautix
-128.87
± 143.885
Cohort C: Placebo
-141.30
± 139.439
Cohort D: Blautix
-125.75
± 135.258
Cohort D: Placebo
-100.97
± 114.939
Change at Week 8
Group
Value
95% CI
Cohort C: Blautix
-168.46
± 157.300
Cohort C: Placebo
-173.53
± 155.253
Cohort D: Blautix
-143.55
± 143.781
Cohort D: Placebo
-133.63
± 139.290
Change at Follow-up visit
Group
Value
95% CI
Cohort C: Blautix
-142.49
± 149.678
Cohort C: Placebo
-160.66
± 150.174
Cohort D: Blautix
-113.47
± 135.064
Cohort D: Placebo
-104.76
± 146.447
Change From Baseline in Hospital Anxiety and Depression (HADS) Total Score at Week 4, 8 and Follow-up Visit (Weeks 12-14)Secondary· Baseline, Week 4, 8, follow-up visit (Weeks 12-14)
Participants were asked to complete the HADS which was a 14-item scale (7 items- anxiety and 7 items-depression) that generated ordinal data. Each question was rated on a scale from 0 - 3. The outcome of the HADS questionnaire was two total scores, the HADS-A (for anxiety) and the HADS-D (for depression). Both total scores are graded on a scale of 0 - 21 and can be categorized as Normal (0 - 7), Borderline Abnormal (8 - 10) and Abnormal (11 - 21). Higher scores indicate higher levels of anxiety and depression. A negative change from Baseline indicates improvement.
Change at Week 4: Anxiety total score
Group
Value
95% CI
Cohort C: Blautix
-0.02
± 2.612
Cohort C: Placebo
0.22
± 2.954
Cohort D: Blautix
0.09
± 2.827
Cohort D: Placebo
-0.27
± 3.243
Change at Week 4: Depression total score
Group
Value
95% CI
Cohort C: Blautix
0.24
± 3.527
Cohort C: Placebo
-0.29
± 3.303
Cohort D: Blautix
0.22
± 2.566
Cohort D: Placebo
0.00
± 2.410
Change at Week 8: Anxiety total score
Group
Value
95% CI
Cohort C: Blautix
0.08
± 2.981
Cohort C: Placebo
-0.09
± 3.320
Cohort D: Blautix
-0.32
± 3.251
Cohort D: Placebo
-0.40
± 3.213
Change at Week 8: Depression total score
Group
Value
95% CI
Cohort C: Blautix
-0.18
± 3.432
Cohort C: Placebo
-0.06
± 3.556
Cohort D: Blautix
0.19
± 2.787
Cohort D: Placebo
-0.36
± 3.169
Change at Follow-up visit: Anxiety total score
Group
Value
95% CI
Cohort C: Blautix
-0.53
± 3.360
Cohort C: Placebo
0.06
± 2.714
Cohort D: Blautix
-0.14
± 3.029
Cohort D: Placebo
-0.55
± 3.375
Change at Follow-up visit: Depression total score
Group
Value
95% CI
Cohort C: Blautix
-0.85
± 3.735
Cohort C: Placebo
-0.14
± 2.939
Cohort D: Blautix
0.51
± 3.024
Cohort D: Placebo
-0.68
± 2.886
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to follow-up visit (up to Week 14).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort C: Blautix
Serious: 0/80 (0%)
Deaths: 0/80
Cohort C: Placebo
Serious: 0/84 (0%)
Deaths: 0/84
Cohort D: Blautix
Serious: 1/97 (1%)
Deaths: 0/97
Cohort D: Placebo
Serious: 1/104 (1%)
Deaths: 0/104
Serious adverse events (2 terms)
Reaction
System
Cohort C: Blautix
Cohort C: Placebo
Cohort D: Blautix
Cohort D: Placebo
Atrial fibrillation
Cardiac disorders
—
—
—
—
Cellulitis
Infections and infestations
—
—
—
—
Other adverse events (100 terms — click to expand)
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by 4D pharma plc
Last refreshed: 11 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03721107.