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Effect of Probiotic Supplementation on Schizophrenia Symptoms and Association With Gastrointestinal Functioning: A Randomized, Placebo-Controlled Trial
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Article Abstract Objective: A range of immune system abnormalities have been associated with schizophrenia. Probiotic compounds modulate the immune response and offer a potential treatment strategy for schizophrenia. Probiotic compounds have also been observed to improve gastrointestinal dysfunction, which is a common problem in individuals with schizophrenia. We performed a randomized, double-blind, placebo-controlled trial to examine whether probiotic supplementation can reduce symptom severity in patients with schizophrenia receiving antipsychotic treatment and also whether probiotics are associated with bowel functioning. Methods: Outpatients with schizophrenia (N = 65) meeting DSM-IV criteria and with at least moderately severe psychotic symptoms were enrolled in the study from December 2010-August 2012. Following a 2-week placebo run-in period, patients were randomly assigned to 14 weeks of double-blind adjunctive probiotic (combined Lactobacillus rhamnosus strain GG and Bifidobacterium animalis subsp. lactis strain Bb12) or placebo therapy. Psychiatric symptoms were assessed biweekly with the Positive and Negative Syndrome Scale (PANSS), and patients were queried weekly about their gastrointestinal functioning. Results: Repeated-measures analysis of variance showed no significant differences in the PANSS total score between probiotic and placebo supplementation (F = 1.28, P = .25). However, patients in the probiotic group were less likely to develop severe bowel difficulty over the course of the trial (hazard ratio = 0.23; 95% CI, 0.09-0.61, P = .003). Conclusions: Probiotic supplementation may help prevent a common somatic symptom associated with schizophrenia. Trial Registration: ClinicalTrials.gov identifier: NCT01242371 Prim Care Companion CNS Disord 2014;16(1):doi:10.4088/PCC.13m01579 © Copyright 2014 Physicians Postgraduate Press, Inc. Submitted: September 6, 2013; accepted October 18, 2013. Published online: February 13, 2014. Corresponding author: Faith B. Dickerson, PhD, Stanley Research Program at Sheppard Pratt, Sheppard Pratt Health System, 6501 North Charles St, Baltimore, MD 21204 (fdickerson@sheppardpratt.org).
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“However, the use of Lactobacillus rhamnosus strain GG and Bifidobacterium animalis subsp. lactis strain Bb12 did not have an effect on PANSS scores in SZ patients in a 14-week trial [37].”
From Effect of Supplementation with Probiotics in Patients with Schizophrenia: Systematic Review and Meta-Analysis of Randomized Controlled Clinical Trials (2025) · cites this paper as [37]
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“Five clinical studies on SZ were published but showed inconsistent results regarding the enhancement of neuropsychiatric symptoms (Dickerson et al., 2014; Ghaderi et al., 2019; Okubo et al., 2018; Severance et al., 2017; Tomasik, Yolken, Bahn, & Dickerson, 2015).”
ResultThe effects of antipsychotic medications on microbiome and weight gain in children and adolescents
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“With respect to probiotic administration in patients with SCZ, Dickerson et al. (2014) performed a double blind randomized controlled trial to determine whether probiotic supplementation with Bifidobacteria could alleviate psychotic symptoms measured by the Positive and Negative Syndrome Scale…”
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“Interestingly, fecal microbiota transplants from psychiatric patients to germ-free rodents have been shown to induce symptoms similar Abbreviations: BDI, Beck Depression Inventory; BMI, body mass index; CFU, colony forming units; DSM, Diagnostic and Statistical Manual of Mental Disorders; EC, enterochromaffin cells; G…”
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The Role of the Gut Microbiome in Psychiatric Disorders
Andrioaie, I.-M., Duhaniuc, A., Năstase, E. V., Iancu, L. S., Luncă, C., Trofin, F., Anton-Păduraru, D.-T., & Dorneanu, O. (2022) · Microorganisms · doi:10.3390/microorganisms10122436 · Cited by 49
“However, one of the studies showed that probiotics may have a beneficial role on adverse effects associated with antipsychotic use, such as weight gain and constipation [75].”
Gut microbiome in schizophrenia and antipsychotic-induced metabolic alterations: a scoping review
Singh, R., Stogios, N., Smith, E., Lee, J., Maksyutynska, K., Au, E., Wright, D. C., Palma, G. D., Graff‐Guerrero, A., Gerretsen, P., et al. (2022) · Therapeutic Advances in Psychopharmacology · doi:10.1177/20451253221096525 · Cited by 44
Vasiliu, O. (2023) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2023.1074736 · Cited by 42
Ketogenic diet for schizophrenia: Nutritional approach to antipsychotic treatment
Włodarczyk, A., Wiglusz, M. S., & Cubała, W. J. (2018) · Medical Hypotheses · doi:10.1016/j.mehy.2018.06.022 · Cited by 44
Inflammation in Mental Disorders: Is the Microbiota the Missing Link?
Marin, S., Hé, Y., Butler, K., & Tsuang, M. T. (2020) · Neuroscience Bulletin · doi:10.1007/s12264-020-00535-1 · Cited by 44
“They selected only one study concerning SCZ in which Dickerson et al. (2014) found that repeated-measures analysis of variance showed no significant differences in the total score on the Positive and Negative Symptom Scale (PANSS) between probiotic and placebo supplementation [147].”
Microglial contribution to the pathology of neurodevelopmental disorders in humans
Matulevičiūtė, R., Akinluyi, E. T., Muntslag, T. A. O., Dewing, J. M., Long, K. R., Vernon, A. C., Tremblay, M., & Menassa, D. A. (2023) · Acta Neuropathologica · doi:10.1007/s00401-023-02629-2 · Cited by 41
“Microbiome-modulating therapies such as prebiotics [55, 87], probiotics [33, 166], synbiotics [210], and fecal microbiome transplantation [86] have been shown to improve behavioural outcomes in patients with ASCs and SZ (reviewed in [189] by modulating micro-glial maturation and reactivity via…”
BackgroundFrom Infection to the Microbiome: An Evolving Role of Microbes in Schizophrenia
Severance, E. G., & Yolken, R. H. (2019) · Current topics in behavioral neurosciences · doi:10.1007/7854_2018_84 · Cited by 40
Self-citationCuomo, A., Maina, G., Rosso, G., Crescenzi, B. B., Bolognesi, S., Muro, A. D., Giordano, N. G., Goracci, A., Neal, S. M., Nitti, M. P., et al. (2018) · Frontiers in Pharmacology · doi:10.3389/fphar.2018.01040 · Cited by 39
Gut microbiome and schizophrenia: insights from two-sample Mendelian randomization
Zhou, K., Baranova, A. V., Cao, H., Sun, J., & Zhang, F. (2024) · Schizophrenia · doi:10.1038/s41537-024-00497-7 · Cited by 40
Deidda, G., & Biazzo, M. (2021) · Frontiers in Neuroscience · doi:10.3389/fnins.2021.753915 · Cited by 37
Delcaru, C., Alexandru, I., Podgoreanu, P., Cristea, V. C., Bleoţu, C., Chifiriuc, M. C., Bezirtzoglou, E., & Lazăr, V. (2016) · Anaerobe · doi:10.1016/j.anaerobe.2016.02.010 · Cited by 36
A narrative review on the use of probiotics in several diseases. Evidence and perspectives
Campaniello, D., Bevilacqua, A., Speranza, B., Racioppo, A., Sinigaglia, M., & Corbo, M. R. (2023) · Frontiers in Nutrition · doi:10.3389/fnut.2023.1209238 · Cited by 36
Antipsychotics and the microbiota
Chen, A., Park, T. Y., Li, K. J., & DeLisi, L. E. (2020) · Current Opinion in Psychiatry · doi:10.1097/yco.0000000000000594 · Cited by 34
“[32] have both shown that probiotic can help with antipsychotic-induced gastrointestinal discomfort .”
BackgroundAhmadvand, A., Sepehrmanesh, Z., Shahzeidi, A., Mansournia, M. A., & Ghaderi, A. (2021) · International Archives of Health Sciences · doi:10.4103/iahs.iahs_112_20 · Cited by 31
Flach, J., van der Waal, M., Kardinaal, A., Schloesser, J., Ruijschop, R., & Claassen, E. (2018) · Cogent Food & Agriculture · doi:10.1080/23311932.2018.1452839 · Cited by 37
“Dickerson et al. (2014) recruited 65 patients with schizophrenia symptoms who tend to have a high prevalence of GI problems, especially constipation.”
BackgroundBen‐Azu, B., del Re, E. C., VanderZwaag, J., Carrier, M., Keshavan, M. S., Khakpour, M., & Tremblay, M. (2023) · Frontiers in Cellular Neuroscience · doi:10.3389/fncel.2023.1139357 · Cited by 32
“lactis strain Bb12 was conducted on DSM-IV confirmed-psychotic patients (Dickerson et al., 2014).”
MethodMarć, M. A., Jastrząb, R., & Mytych, J. (2022) · Nutrients · doi:10.3390/nu14193967 · Cited by 33
Mohammadi, A., Sadighi, G., Astaneh, A. N., Ebrahimi, M. T., & Dejam, T. (2024) · Neuropsychopharmacology Reports · doi:10.1002/npr2.12431 · Cited by 33
“11,12 Probiotics can change the balance of the gut microbiota and prevent inappropriate immune responses to the harmful antigens originated from the gut lumen.”
BackgroundMicrobial Therapeutics in Neurocognitive and Psychiatric Disorders
Alagiakrishnan, K., & Halverson, T. (2021) · Journal of Clinical Medicine Research · doi:10.14740/jocmr4575 · Cited by 29
Ling, Z., Lan, Z., Cheng, Y., Liu, X., Li, Z., Yu, Y., Wang, Y., Shao, L., Zhu, Z., Gao, J., et al. (2024) · Journal of Translational Medicine · doi:10.1186/s12967-024-05533-9 · Cited by 27
“However, several studies also demonstrated that probiotic administration had no significant difference on the PANSS scale [85, 86], suggesting that the efficacy for SZ-MetS may depend on the specific probiotic strains used.”
BackgroundKarczewski, J., Zielińska, A., Staszewski, R., Eder, P., Dobrowolska, A., & Souto, E. B. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms23116145 · Cited by 27
Misera, A., Łoniewski, I., Palma, J., Kulaszyńska, M., Czarnecka, W., Kaczmarczyk, M., Liśkiewicz, P., Samochowiec, J., & Skonieczna‐Żydecka, K. (2023) · Frontiers in Microbiology · doi:10.3389/fmicb.2023.1125022 · Cited by 28
A review on the relationship between gluten and schizophrenia: Is gluten the cause?
Ergün, C., Urhan, M., & Ayer, A. (2017) · Nutritional Neuroscience · doi:10.1080/1028415x.2017.1313569 · Cited by 28
Joseph, J., & Law, C. A. (2018) · Neuroscience & Biobehavioral Reviews · doi:10.1016/j.neubiorev.2018.11.010 · Cited by 26
Molavi, N., Rasouli‐Azad, M., Mirzaei, H., Matini, A. H., Banafshe, H. R., Valiollahzadeh, M., Hassanzadeh, M., Saghazade, A. R., Abbaszadeh‐Mashkani, S., Mamsharifi, P., et al. (2022) · International Journal of Clinical Practice · doi:10.1155/2022/1206914 · Cited by 26
“In addition, no significant improvement was observed in patients with schizophrenia following treatment with Lactobacillus rhamnosus and Bifidobacterium supplements for 14 weeks [60].”
Modulation of Gut Microbial Diversity through Non-Pharmaceutical Approaches to Treat Schizophrenia
Munawar, N., Ahmad, A., Anwar, M. A., & Muhammad, K. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms23052625 · Cited by 28
Diamanti, T., Prete, R., Battista, N., Corsetti, A., & Jaco, A. D. (2022) · Antibiotics · doi:10.3390/antibiotics11121767 · Cited by 27
An anxious relationship between Autism Spectrum Disorder and Gut Microbiota: A tangled chemistry?
Vellingiri, B., Aishwarya, S. Y., Jancy, S. B., Abhishek, G. S., Babu, H. W. S., Vijayakumar, P., Narayanasamy, A., Mariappan, S., Sangeetha, R., Gopalakrishnan, A. V., et al. (2022) · Journal of Clinical Neuroscience · doi:10.1016/j.jocn.2022.03.003 · Cited by 23
Schizophrenia and obesity: May the gut microbiota serve as a link for the pathogenesis?
Wu, H., Liu, Y., Wang, J., Chen, S., Xie, L., & Wu, X. (2023) · iMeta · doi:10.1002/imt2.99 · Cited by 24
Talani, G., Biggio, F., Mostallino, M. C., Locci, V., Porcedda, C., Boi, L., Saolini, E., Piras, R., Sanna, E., & Biggio, G. (2019) · Neuropharmacology · doi:10.1016/j.neuropharm.2019.107909 · Cited by 24
Zajkowska, I., Niczyporuk, P., Urbaniak, A. D., Tomaszek, N., Modzelewski, S., & Waszkiewicz, N. (2024) · Nutrients · doi:10.3390/nu16142228 · Cited by 24
“Dickerson et al. reported no significant differences in PANSSs following 14 weeks of supplementation with Lactobacillus rhamnosus strain GG and Bifidobacterium animalis subsp. lactis strain Bb12 among 65 individuals diagnosed with SCZ [63].”
BackgroundHawkins, B., Montgomery, M., Bokota, G., Santoyo, M., Giron, E., & Eltokhi, A. (2025) · Gut Microbes · doi:10.1080/19490976.2025.2574934 · Cited by 24
“199 However, providing important context for probiotic limitations, large trials with Lactobacillus rhamnosus GG plus Bifidobacterium animalis showed no PANSS changes, 200,201 though targeting the mycobiome reduced Candida albicans IgG in a preclinical rat study.”
Sex-related patterns of the gut-microbiota-brain axis in the neuropsychiatric conditions
Manosso, L. M., Lin, J. H. X., Carlessi, A. S., Recco, K. C. C., Quevedo, J., Gonçalves, C. L., & Réus, G. Z. (2021) · Brain Research Bulletin · doi:10.1016/j.brainresbull.2021.04.001 · Cited by 23
Zeng, C., Qiu, Y., Li, S., Teng, Z., Xiang, H., Chen, J., Wu, X., Cao, T., Zhang, S., Chen, Q., et al. (2022) · Frontiers in Pharmacology · doi:10.3389/fphar.2022.829815 · Cited by 20
“Although probiotic administration containing Lactobacillus rhamnosus strain GG and Bifidobacterium had no apparent therapeutic effects on the psychopathology, it may help prevent common somatic symptom associated with schizophrenia after 14 weeks (Dickerson et al., 2014).”
BackgroundHassib, L., Kanashiro, A., Pedrazzi, J. F. C., Vercesi, B. F., Higa, S., Arruda, Í., Soares, Y., de Souza, A. P., Barichello, T., Guimarães, F. S., et al. (2025) · Progress in Neuro-Psychopharmacology and Biological Psychiatry · doi:10.1016/j.pnpbp.2025.111385 · Cited by 19
Delaney, S., & Hornig, M. (2018) · Current Environmental Health Reports · doi:10.1007/s40572-018-0186-z · Cited by 21
Metadata
- Authors
- Dickerson, F. B., Stallings, C., Origoni, A., Katsafanas, E., Savage, C. L. G., Schweinfurth, L. A. B., Goga, J., Khushalani, S., & Yolken, R. H.
- Affiliations
- Johns Hopkins University (US)
- Corresponding author
- Dickerson, Faith B.
- ORCID
- Venue
- The Primary Care Companion For CNS Disorders
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2014-02-13
- Volume
- 16
- Issue
- 1
- ISSN
- 2155-7772 (ISSN-L)
- 2155-7780
- PMC
- PMC4048142
- OpenAlex
- W2088974372
- Cited by
- 166
- References
- 27
- Citations by year
- 2026: 2 · 2025: 10 · 2024: 15 · 2023: 15 · 2022: 25 · 2021: 15 · 2020: 19 · 2019: 18 · 2018: 17 · 2017: 9 · 2016: 11 · 2015: 8 · 2014: 1
- FWCI
- 13.86
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Primary Care Companion For CNS Disorders (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Keywords
- probiotics, schizophrenia, gastrointestinal dysfunction, antipsychotic drugs, immune abnormalities, symptom severity, adjunctive therapy
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